A randomized,controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers

HYPOTHESIS: Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers. DESIGN: Randomized, prospective, controlled multicenter trial. SETTING: University teaching hospitals and primary care centers. PATIENTS: A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer. INTERVENTIONS: Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks. MAIN OUTCOME MEASURE: Complete healing of the study ulcer (wound). RESULTS: After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze. CONCLUSIONS: Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.     

Effect of noncontact normothermic wound therapy on the healing of neuropathic (diabetic) foot ulcers: An interim analysis of 20 patients

This is the interim analysis of a prospective, randomized, controlled study comparing diabetic foot ulcer healing in patients being treated with either noncontact normothermic wound therapy (Warm-UP; Augustine Medical Inc. Eden Prairie, MN) applied for 1 hour 3 times daily until healing or 12 weeks, or standard care (saline-moistened gauze applied once a day). Surgical debridement and adequate foot off-loading was provided to both groups. Evaluations were performed weekly and consisted of acetate tracings, wound assessment, and serial photography. Twenty patients have completed the trial and both treatment groups were distributed evenly (N = 10). Ulcers treated with noncontact normothermic wound therapy had a greater mean percent wound closure than control-treated ulcers at each evaluation point (weeks 1-12). After 12 weeks, 70% of the wounds treated with noncontact normothermic wound therapy were healed compared with 40% for the control group. In this subset of patients there have been no adverse events associated with noncontact normothermic wound therapy.     

Healing of diabetic foot ulcers and pressure ulcers with human skin equivalent: a new paradigm in wound healing

HYPOTHESIS: In patients with diabetic foot and pressure ulcers, early intervention with biological therapy will either halt progression or result in rapid healing of these chronic wounds. DESIGN: In a prospective nonrandomized case series, 23 consecutive patients were treated with human skin equivalent (HSE) after excisional debridement of their wounds. SETTING: A single university teaching hospital and tertiary care center. PATIENTS AND METHODS: Twenty-three consecutive patients with a total of 41 wounds (1.0-7.5 cm in diameter) were treated with placement of HSE after sharp excisional debridement. All patients with pressure ulcers received alternating air therapy with zero-pressure alternating air mattresses. MAIN OUTCOME MEASURE: Time to 100% healing, as defined by full epithelialization of the wound and by no drainage from the site. RESULTS: Seven of 10 patients with diabetic foot ulcers had complete healing of all wounds. In these patients 17 of 20 wounds healed in an average of 42 days. Seven of 13 patients with pressure ulcers had complete healing of all wounds. In patients with pressure ulcers, 13 of 21 wounds healed in an average of 29 days. All wounds that did not heal in this series occurred in patients who had an additional stage IV ulcer or a wound with exposed bone. Twenty-nine of 30 wounds that healed did so after a single application of the HSE. CONCLUSIONS: In diabetic ulcers and pressure ulcers of various durations, the application of HSE with the surgical principles used in a traditional skin graft is successful in producing healing. The high success rate with complete closure in these various types of wounds suggests that HSE may function as a reservoir of growth factors that also stimulate wound contraction and epithelialization. If a wound has not fully healed after 6 weeks, a second application of HSE should be used. If the wound is not healing, an occult infection is the likely cause. All nonischemic diabetic foot and pressure ulcers that are identified and treated early with aggressive therapy (including antibiotics, off-loading of pressure, and biological therapy) will not progress.     

The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study

A prospective, single-centre, randomized controlled study was performed to evaluate the effectiveness of Graftjacket, a human acellular regenerative tissue matrix as a treatment option for chronic non healing lower extremity wounds. Twenty-eight diabetic patients with full-thickness wounds that had been present for at least 6 weeks were treated with sharp debridement and randomized to a single application of Graftjacket tissue matrix plus mineral oil-soaked fluff compression dressing or to a control treatment of wound gel with gauze dressings. All patients were seen weekly. By week 16, 12 of 14 patients treated with Graftjacket tissue matrix demonstrated complete wound closure compared with 4 of 14 patients in the control group. Patients treated with Graftjacket tissue matrix showed a statistically significant higher percentage of wound healing with respect to wound area, and clinically significant differences in wound depth and wound volume. This comparison is not performed to demonstrate that the application of the Grafjacket is more effective than sharp debridement. This study is done to help assign a role to the use of Graftjacket matrix in lower extremity wound care.     

The cell based dressing with living allogenic keratinocytes in the treatment of foot ulcers: a case study.

In this study, we aimed to investigate the efficacy of cell based dressing with living allogenic keratinocytes in diabetic foot patients. To address this issue, the cultured keratinocytes were attached to the microcarriers produced from polyethylene and silica. The microcarriers were then applied to the wounds at 3-day intervals. Forty patients with grade II and III diabetic foot ulcers were included into the study. The patients were randomised into two groups (n=20). The treatment and control groups received cell based dressing and microcarriers kept in culture medium overnight, respectively. The wound size was recorded at 3 days intervals. The wounds were also categorised by a specific scoring system considering the wound contraction, granulation tissue formation, epithelisation and discharge from the wounds. The high score indicates better condition. The mean reduction of the wound area was 92% in the treatment group and 32% in the control group at the end of the 30 days treatment (p<0.001). When considered the complete healing, the mean number of dressings was 9.2+/-3.2 in the treatment group whereas it was 16.5+/-2.3 in the control group (p<0.001). The initial mean score of the treatment and control groups were 2.5 and 2.35, respectively. At the end of the 30th day, the mean score of the treatment group was 17.15+/-2.7 and of control group was 9.05+/-3. Allogenic keratinocyte treatment delivered with microcarriers can make significant contributions to wound healing in diabetic foot patients.     

异种(猪)脱细胞真皮基质一次性包扎治疗深Ⅱ度烧伤

目的探讨应用异种(猪)脱细胞真皮基质一次性包扎治疗深Ⅱ度烧伤创面的临床应用效果。方法1997年1月—2004年1月,应用异种(猪)脱细胞真皮基质一次包扎治疗50%~95%总体表面积(TBSA)、深Ⅱ度烧伤的患者67例[异种(猪)脱细胞真皮基质治疗组];同期保痂治疗的50%~95%TBSA、深Ⅱ度的患者10例(保痂治疗组),观察创面愈合时间和愈合质量及其并发症发生情况。治愈患者经过3个月~2年的随诊,观察瘢痕增生情况。结果异种(猪)脱细胞真皮基质治疗组深Ⅱ度创面中途基本不需换药,创面愈合时间缩短,平均(12.2±2.6)d,而保痂治疗组愈合时间为(27.4±3.5)d,差异具有统计学意义(P<0.05);同时,异种(猪)脱细胞真皮基质治疗组瘢痕增生情况较保痂治疗组明显减轻或者无瘢痕增生。结论一次性覆盖异种(猪)脱细胞真皮基质可有效地治疗深Ⅱ度烧伤创面,能加快创面愈合,减轻瘢痕增生,从而降低烧伤感染和炎症反应综合征的发生。     

Débridement and primary closure of nonhealing foot wounds

Fifty-eight chronic nonhealing foot wounds (51 patients) were treated with irrigation, aggressive débridement, and primary tension-free closure. Factors such as wound location, wound size, presence of infection, and healing outcome were recorded. In addition, medical comorbidities and preoperative laboratory test results were reviewed. Thirty-seven (64%) of the 58 wounds healed after primary closure. Of the other 21 wounds, 16 healed after repeat irrigation, debridement, and closure or local wound care; 2 patients were lost to follow-up after initial failed wound healing, 1 patient died after initial failed wound healing, and 2 cases were salvaged with amputation. Failed primary closures were thought not to increase wound size; all but 3 of these closures decreased wound size significantly. Differences between the wounds that healed primarily and the wounds that failed healing were not statistically significant. Diabetes was present in 46% of the patients whose wounds healed primarily versus 71% of the patients whose wounds failed healing (P = .06). Irrigation, débridement, and primary closure of nonhealing foot wounds can be a useful treatment option for most such patients. Complete healing or reduced wound size occurs in 95% of cases.     

An aseptically processed,acellular, reticular,allogenic human dermis improves healing in diabetic foot ulcers: A prospective,randomised, controlled,multicentre follow‐up trial

Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR‐ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty‐eight percent (27/40) in the HR‐ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR‐ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft‐related adverse events. The mean and median HR‐ADM product costs at 12 weeks were $1200 and $680, respectively. HR‐ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non‐healing diabetic foot ulcers.     

A prospective,randomised, controlled,multicentre clinical trial examining healing rates,safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers

Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open‐structure human reticular acellular dermis matrix (HR‐ADM) to facilitate wound closure in non‐healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2‐week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR‐ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR‐ADM‐treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR‐ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR‐ADM group were $1475 and $963, respectively. Weekly application of HR‐ADM is an effective intervention for promoting closure of non‐healing DFUs.     

A parallel open-label trial to evaluate microbial cellulose wound dressing in the treatment of diabetic foot ulcers

The purpose of this study was to compare the rate of wound healing in diabetic foot ulcers (DFU) using either a microbial cellulose (MC) wound dressing or Xeroform? Petrolatum gauze. In a parallel, open‐label trial in which the primary outcome was the rate of wound healing and the time to wound closure, 15 ulcers in type II diabetic patients received an MC dressing. Wounds in 19 control patients with type II diabetes were treated with a Xeroform gauze dressing. All wounds were non infected, Wagner stage II or III and received standard care including debridement, non weight bearing limb support and weekly wound evaluation. The mean time to heal in the MC (±SE) treated group was 32 days ± 2·5 and for controls it was 48 days ± 4·7 (P < 0·01). The rate of weekly wound closure (mean ± SE) was 1·7 times faster in the MC‐treated group (cellulose treated, ?5·04% per week ± 0·38 versus control, ?2·93% per week ± 0·19), (P < 0·001). Among covariants tested by univariate regression, only the original wound area correlated with the time to wound closure (P < 0·001). In conclusion, with the provision of current standards of care, the application of an MC dressing to a diabetic ulcer may enhance the rate of wound healing and shorten the time course of epithelisation.     

Healing of full-thickness wounds treated with lyophilized cultured keratinocyte cell lysate in genetically diabetic mice

The effect of a lyophilized cell lysate prepared from cultured human keratinocytes on the healing of full-thickness wounds was evaluated in an impaired healing model. Full-thickness wounds (8 mm in diameter) were made on the dorsal areas of female genetically diabetic mice C57 BL/KsJ (db/db) and their normal (db/+) littermates. Wounds were covered with an occlusive polyurethane film dressing and were treated for 5 days either with the lyophilized cell lysate from cultured human keratinocytes prepared in phosphate-buffered saline solution or with phosphate-buffered saline solution. In normal (db/+) mice, all wounds were closed 16 days after wounding, and more than 90% of the wound closure was due to wound contraction. Wound contraction accounted for a similar extent of wound closure in both lyophilized cell lysate-treated and phosphate-buffered saline solution-treated wounds. In contrast, in the diabetic (db/db) mice, after histologic examination of the wounds 32 days after wounding, four of ten lyophilized cell lysate-treated wounds and four of seven phosphate-buffered saline-treated wounds were found to be closed. Moreover, applications of lyophilized cell lysate from cultured human keratinocytes to full-thickness wounds in diabetic db/db mice significantly decreased the contribution of contraction to wound closure. Day 32 after wounding, contraction contribution to wound closure amounted to 57.7%+/- 4.7% and 80.4%+/- 3.2% (mean +/- standard error of the mean, p < 0.005) of the initial wound areas, respectively, for lyophilized cell lysate-treated and phosphate-buffered saline solution-treated wounds. At this time of wound healing, the thickness of the dermis was increased 1.7-fold by the keratinocyte cell lysate treatment, but neither epithelial migration from the wound edges nor the thickness of the regenerated epithelium were significantly affected. In conclusion, in diabetic (db/db) mice the application of lyophilized cell lysate from cultured human keratinocytes influenced the healing of the dermis and wound contraction, but had no effect on reepithelialization.     

Partial breast reconstruction of 30 cases with peri-mammary artery perforator flaps

Self-repair of lower limb wounds has always been one of the research hotspots. Flaps and skin graft are the preferred treatment for lower extremity wound reconstruction. However, these treatments have many disadvantages, such as secondary damage, poor healing quality. In recent years, the use of acellular dermal matrix has emerged as an alternative treatment option for extremity ulcers. This study aimed to explore whether acellular dermal matrix can be used as a single treatment to promote wound healing. 7 patients with lower extremities cutaneous deficiency exposing bone or tendon, were covered by Pelnac, which was an acellular dermal matrix product approved by China Food and Drug Administration. All the wound was treated by Pelnac without flaps and skin graft. The external dressing was changed every 10 days. After a maximum of 20 weeks, all the wounds were completely healed. During the 12 months follow-up period none of the patients developed skin wear on the treatment area. All patients maintained their postoperative ambulatory ability. All patients were satisfied with the appearance and feeling after wound healing. These findings may mean acellular dermal matrix is a novel method offering opportunity for treatment of lower extremities cutaneous deficiency exposing bone or tendon. It also has the potential to close wounds of all uninfected, non-ischemic, full-thickness cutaneous deficiency.     

Negative pressure wound therapy via vacuum assisted closure following partial foot amputation: what is the role of wound chronicity?

Randomised clinical trials (RCTs) to evaluate diabetic foot wound therapies have systematically eliminated large acute wounds from evaluation, focusing only on smaller chronic wounds. The purpose of this study was to evaluate the proportion and rate of wound healing in acute and chronic wounds after partial foot amputation in individuals with diabetes treated with negative pressure wound therapy (NPWT) delivered by the vacuum-assisted closure (VAC) device or with standard wound therapy (SWT). This study constitutes a secondary analysis of patients enrolled in a 16-week RCT of NPWT: 162 open foot amputation wounds (mean wound size = 20.7 cm(2)) were included. Acute wounds were defined as the wounds less than 30 days after amputation, whereas chronic wounds as the wounds greater than 30 days. Inclusion criteria consisted of individuals older than 18 years, presence of a diabetic foot amputation wound up to the transmetatarsal level and adequate perfusion. Wound size and healing were confirmed by independent, blinded wound evaluators. Analyses were done on an intent-to-treat basis. There was a significantly higher proportion of acute wounds (SWT = 59; NPWT = 63) than chronic wounds (SWT = 26; NPWT = 14), evaluated in this clinical trial (P = 0.001). There was no significant difference in the proportion of acute and chronic wounds achieving complete wound closure in either treatment group. Despite this finding, the Kaplan-Meier curves demonstrated statistically significantly faster healing in the NPWT group in both acute (P = 0.030) and chronic wounds (P = 0.033). Among the patients treated with NPWT via the VAC, there was not a significant difference in healing as a function of chronicity. In both the acute and the chronic wound groups, results for patients treated with NPWT were superior to those for the patients treated with SWT. These results appear to indicate that wound duration should not deter the clinician from using this modality to treat complex wounds.     

A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator

This study compared the efficacy and safety of a human acellular dermal matrix (ADM), D‐ADM, with a conventional care arm and an active comparator human ADM arm, GJ‐ADM, for the treatment of chronic diabetic foot ulcers. The study design was a prospective, randomized controlled trial that enrolled 168 diabetic foot ulcer subjects in 13 centers across 9 states. Subjects in the ADM arms received one application but could receive one additional application of ADM if deemed necessary. Screen failures and early withdrawals left 53 subjects in the D‐ADM arm, 56 in the conventional care arm, and 23 in the GJ‐ADM arm (2:2:1 ratio). Subjects were followed through 24 weeks with major endpoints at Weeks 12, 16, and 24. Single application D‐ADM subjects showed significantly greater wound closure rates than conventional care at all three endpoints while all applications D‐ADM displayed a significantly higher healing rate than conventional care at Week 16 and Week 24. GJ‐ADM did not show a significantly greater healing rate over conventional care at any of these time points. A blinded, third party adjudicator analyzed healing at Week 12 and expressed “strong” agreement (κ = 0.837). Closed ulcers in the single application D‐ADM arm remained healed at a significantly greater rate than the conventional care arm at 4 weeks posttermination (100% vs. 86.7%; p = 0.0435). There was no significant difference between GJ‐ADM and conventional care for healed wounds remaining closed. Single application D‐ADM demonstrated significantly greater average percent wound area reduction than conventional care for Weeks 2–24 while single application GJ‐ADM showed significantly greater wound area reduction over conventional care for Weeks 4–6, 9, and 11–12. D‐ADM demonstrated significantly greater wound healing, larger wound area reduction, and a better capability of keeping healed wounds closed than conventional care in the treatment of chronic DFUs.     

Effects of nitric oxide releasing poly(vinyl alcohol) hydrogel dressings on dermal wound healing in diabetic mice

Healing of chronic wounds such as diabetic foot ulcers is a significant clinical problem. Methods of accelerating healing in these difficult lower extremity sites include use of growth factor-loaded gels, hyperbaric oxygen, grafts, and artificial skin replacements. Nitric oxide (NO) has been proposed as a possible active agent for enhancing wound healing. This study examines the in vitro and in vivo responses to a novel hydrogel that produces therapeutic levels of NO. A hydrogel wound dressing was fabricated using ultraviolet light-initiated polymerization from poly(vinyl alcohol) with a NO donor covalently coupled to the polymer backbone. NO release from the NO-modified hydrogel was shown to occur over a time period of up to 48 hours, and there was no associated decrease in fibroblast growth or viability in vitro associated with NO hydrogels. Fibroblasts in culture with NO hydrogels had an increased production of extracellular matrix compared with cells cultured without the NO hydrogels. Preliminary animal studies in a diabetic mouse, impaired wound healing model were conducted comparing low (0.5 mM) and high (5 mM) doses of NO. Time to complete closure was similar in control wounds and NO-treated wounds; however, at 8 days control wounds were significantly smaller than NO-treated wounds. By days 10 to 13 this delay was no longer apparent. Granulation tissue thickness within the wounds at days 8 and 15 and scar tissue thickness after wound closure were increased in animals exposed to higher dose NO hydrogels. The results of this study suggest that exogenous NO released from a hydrogel wound dressing has potential to modulate wound healing.     

Additional follow-up with microvascular transfer in the treatment of chronic venous stasis ulcers.

Nine patients presented with non-healing venous ulcers of the lower limb. All had failed both non-surgical and surgical therapies. Following wide wound excision, perforator ligation, and microsurgical reconstruction, all wounds were healed. In two instances, separation at the flap/wound perimeter interface occurred and required additional dressing care to obtain wound closure. This was probably the result of incomplete excision of surrounding liposclerotic soft tissue. At 26 postoperative months, all wounds remained healed. Microsurgical transfer for properly selected patients can achieve healing of recalcitrant venous wounds, both over the intermediate and long term.     

External fixation for surgical off-loading of diabetic soft tissue reconstruction

Early and aggressive treatment of diabetic foot wounds is imperative for the reduction of amputation risk. Whereas sound local wound care is important for successful management; chronic wounds often reach a stagnant point in healing because of diabetic vasculopathy, immunopathy, or neuropathy. The type, size, shape, and location of wound may not always allow primary closure or grafting. In patients with adequate perfusion and in the absence of infection, local advancement flaps are suitable for durable closure. A review and case report demonstrating the use of these flaps with external fixation as an adjunctive therapy for surgical off-loading is presented.     

Quality of life of adults with unhealed and healed diabetic foot ulcers

BACKGROUND: Diabetic foot ulcers cause major treatment morbidity and cost of care. This study evaluated quality of life in patients with unhealed and healed diabetic foot ulcers. METHODS: This was a cross-sectional study of adult diabetic patients (age 45 years or older) treated in a tertiary care foot clinic who had foot ulcers within the preceding 2 years. Patients with other diabetic complications or conditions that would potentially affect quality of life were excluded. Two patient groups of comparable age, gender distribution, and duration of diabetes were studied: 57 patients with unhealed ulcers (minimum duration, 6 months) and 47 patients with healed ulcers. Telephone interviews were done using the Short Form 12 (SF-12) (both groups) and a Cardiff Wound Impact Scale (CWIS) (unhealed ulcer group). RESULTS: The mean SF-12 Physical Component Summary score was significantly lower for the group with unhealed ulcers (unhealed, 35 +/- 8 points; healed, 39 +/- 10 points; p = 0.04); these scores for both groups were significantly lower than published Short Form 36 (SF-36) scores for general, diabetic, and hypertensive populations. The mean SF-12 Mental Component Summary scores of the groups did not differ significantly from each other or from published population scores. CWIS responses showed that patients with unhealed ulcers were frustrated with healing and had anxiety about the wounds, resulting in marked negative impact on the average Well-being Component Score (35 +/- 6 points). CONCLUSIONS: Individuals with diabetic foot ulcers experience profound compromise of physical quality of life, which is worse in those with unhealed ulcers.     

Clinical Classification of Bioengineered Skin Use and Its Correlation with Healing of Diabetic and Venous Ulcers

BACKGROUND: Chronic wounds are being treated with bioengineering skin constructs. Yet, there is no standard way of assessing these wounds. We developed a classification system to evaluate wounds after construct application. The classification system evaluates the early clinical effect of bioengineered skin and early construct appearance giving a total score named the skin substitute score. OBJECTIVE: Apply classification system to both venous and diabetic foot ulcers and determine whether classification system has validity and predictability for healing. METHODS: Evaluated serial photographs in 83 and 78 patients with diabetic foot ulcers and in 84 and 83 patients with venous ulcer on Days 7 and 14, respectively, treated with a bilayered bioengineered skin construct. Applied the classification system and determined the percentages of healed patients. RESULTS: There was a significant correlation between better skin substitute score and complete wound closure for both venous ulcers p=0.002 on Day 7 and p=0.01 on Day 14) and diabetic foot ulcers p=0.0005 on Day 7 and p<0.0001 on Day 14). CONCLUSION: Optimal clinical effect was associated with complete wound closure. As the clinical effect becomes less than optimal continued clinical persistence of the construct becomes important. This classification system seems to have validity in predicting complete wound closure in wounds treated with a bilayered bioengineered skin construct.     

Retrospective observational analysis of the use of an architecturally unique dermal regeneration template (Derma Pure®) for the treatment of hard‐to‐heal wounds

The purpose of this analysis was to evaluate the use of DermaPure, a decellularised human skin allograft, in the treatment of a variety of challenging wounds. This retrospective observational analysis reviewed a total of 37 patients from 29 different wound clinics across the USA. Each patient received one application of DermaPure which was followed until complete closure. A statistical analysis was performed with the end point being complete healing. All wounds on average, had a duration of 56 weeks and healed in an average time of 10·58 weeks. Individual wound categories included diabetic foot ulcers, which healed in 8·21 weeks; venous leg ulcers, which healed in 11·29 weeks; and surgical/traumatic wounds, which healed in 11·8 weeks.