Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis.

A prospective, multicenter, randomized, controlled 12-week study was undertaken to evaluate the effectiveness of a human fibroblast-derived dermis for treating foot ulcers in the diabetic patient. This report summarizes the findings from one center. Following a 2-week screening period, patients were randomized to either human fibroblast-derived dermis (HFDD) (Dermagraft) plus saline-moistened gauze or to the control group (CT) of saline-moistened gauze alone. Effectiveness end points were: 1) wound closure by week 12, 2) time to wound closure, and 3) percent wound closure by week 12. Safety was assessed by review of adverse events and laboratory findings. Patients randomized to HFDD received an application at day 0 and up to seven additional treatments. All patients in each group received shoes with custom-molded inserts and were seen weekly. The study population was comprised of 28 patients (14 HFDD/14 CT) with chronic ulcers (>6 weeks' duration at time of screening). By week 12, significantly more chronic ulcers healed in the HFDD group than in the CT group (71.4% versus 14.3%, p = .003). Healed HFDD patients achieved wound closure significantly faster than CT patients (p = .004). Patients treated with HFDD showed a statistically significant higher percent of wound closure by week 12 than did CT patients (p = .002). The percent of patients who experienced an infection involving their study wound was less in the HFDD group than in the CT group. It was concluded that HFDD is a safe and effective treatment for chronic foot ulcers in diabetic patients.     

糖尿病足溃疡创面的综合治疗

目的：探讨如何促进糖尿病足溃疡创面愈合,降低致残率。方法：对糖尿病足溃疡患者,在积极的内科治疗稳定病情的基础上,采用以创面清创换药,改善局部血运和促进局部组织生长,或采用整形外科手术的方法治疗。结果：52例糖尿病足溃疡创面,除1例因溃疡坏疽创面较深大合并骨髓炎行截肢外,其余均顺利修复。平均随访90．4%,疗效满意率91．5%,出现溃疡复发或有新的皮肤溃疡者8．5%。结论：在全身治疗稳定病情的基础上,积极进行创面处理和整形外科手术的综合治疗是促进糖尿病足溃疡创面早期愈合,缩短病程和降低致残率切实可行的方法。重视糖尿病足患者溃疡愈合出院后的康复指导工作至关重要。     

中西医结合点状植皮治疗糖尿病足溃疡

目的：观察中西医结合点状植皮法对糖尿病足溃疡的修复作用。方法：在174例糖尿病足溃疡患者创面肉芽组织较新鲜,质地坚实,无明显水肿,分泌物较少,周围无急性炎症时植皮,在局麻下,用锐刀切取点状皮片,将皮片均匀置于创面肉芽组织,使皮片深层与肉芽底部紧密接触,皮片间距0.5--1 cm,无菌网眼纱布覆盖固定,敷以生肌象皮膏纱条,无菌干纱布稍加压包扎。结果：植皮数8--60片,平均成活率80%;创面痊愈时间7--28 d,平均18.7 d。结论：中西医结合点状植皮法治疗糖尿病足溃疡,操作简便,疗效显著,创伤小,不需要特殊技术及设备器械。     

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.     

Meta-analysis of randomized controlled trials on hydrocolloid occlusive dressing versus conventional gauze dressing in the healing of chronic wounds

Chronic wound management is a difficult area in surgical practice. A wide range of dressings have been recommended for the management of chronic wounds. The present meta-analysis was undertaken to determine the effectiveness of hydrocolloid dressing (HCD) in the healing of chronic wounds compared with conventional gauze dressing. All available controlled clinical trials published before December 2001 that compared HCD to conventional gauze dressing in the healing of chronic wounds were systematically reviewed. We identified and analysed 12 randomized trials (11 published; 1 unpublished) comprising 693 patients with 819 ulcers. The overall odds ratio under the fixed effect model was 1.72, that is, 72% more ulcers healed completely with HCD than with conventional gauze dressing. This result was both clinically and statistically significant.     

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.     

Recombinant human epidermal growth factor (EGF) to enhance healing for diabetic foot ulcers

This paper studies the healing effect of recombinant human epidermal growth factor (EGF) on chronic diabetic foot ulcers. A total of 89 patients (65 male and 24 female) aged from 36 to 82 years (average of 54) enrolled for the prospective, open-label trial, crossover study. Predetermined criteria were used for diagnosis and classification of ulcer. The average duration of ulcer was 6 months (range from 3 to 27 months) prior to study. Upon study, the ulcers were debrided and treated with hydrocolloid or composite dressing depending on the condition of the wound. If treatment effect was minimal using advanced dressing for 3 weeks, patients were crossed over to twice-a-day treatment with 0.005% EGF and advanced dressing. Among the patients, 21 patients showed improvement using hydrocolloid or composite dressing alone and 68 patients were crossed over to treatment with EGF and advanced dressing. In the EGF-treated patients, complete healing was noted in 52 patients within an average of 46 days (range from 2 to 14 weeks). Recurrence was not noted during the 6-month observation. But 5 patients showed new lesions different from the prior site. Sixteen patients required further interventions. This paper suggests that topical treatment with EGF combined with advanced dressing may have positive effects in promoting healing of chronic diabetic foot wounds.     

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.     

To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial

The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant (p = 0.0019; p = 0.028, respectively). The Integra Flowable Wound Matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers. Ease of use, absence of adverse effects, and a facilitated wound healing process are among the properties of the matrix. These characteristics make it appropriate in the management of diabetic foot ulcers. Additional research will shed more light on the promising advantages of this material in healing diabetic foot ulcers.     

A case report of the treatment of diabetic foot ulcers using a sodium hyaluronate and iodine complex

Diabetic foot ulcers are difficult to heal due to defects in local microvasculature and persistent, concomitant infection. Despite the best medical care, amputation is often a management option for this problem. The authors have developed a new and unique system for wound treatment, which is based on a combination of high molecular weight sodium hyaluronate with an iodine complex-Hyiodine (Contipro C, Dolní Dobrouc, Czech Republic). In this case report, the authors present an observational study on a series of patients with diabetic foot disease with nonhealing wounds treated with Hyiodine. The effect of the HA-iodine complex was studied on 18 patients suffering from complicated foot diabetic wounds. The HA-iodine complex was either spread directly over the wound, or more frequently, gauze was immersed in the HA-iodine complex and then put on/into the wound. Then several layers of dry gauze covered the wound. This dressing was changed every 24 hours. Wound healing was monitored daily, and wound pictures were taken each second week. Clinical improvement was observed in the majority. This suggests that the HA-iodine complex dressing has potential that needs to be developed from controlled studies.     

An open multicenter comparative randomized clinical study on chitosan

Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next‐generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management of chronic wounds.     

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.     

Wound healing trajectories as predictors of effectiveness of therapeutic agents

BACKGROUND: One goal of wound healing research is to discover agents to accelerate healing. Regulatory agencies have suggested stringent criteria to determine efficacy, that of 100% wound closure. Data analysis at a single point such as 100% closure does not provide detailed information about agent effectiveness over the entire span of healing. HYPOTHESIS: Wound healing trajectories can provide such information and can be used to demonstrate utility as alternative end points for wound healing trials. DESIGN: Data from 160 patients in 11 clinical trials of diabetic foot ulcers conducted at 2 centers were evaluated. Wound healing trajectories were constructed for patients whose wounds healed (100% closure) and those whose did not (<100% closure) over a 20-week period. The percentage of patients achieving total healing vs time of treatment was plotted and divided into patients receiving a test agent or placebo. RESULTS: The healing trajectories were almost identical for patients achieving complete healing at the 2 centers, as were the trajectories for patients with less than 100% closure. However, the trajectories of patients achieving total healing were significantly different from those not achieving 100% closure. Fifty-two percent of all patients achieved 100% healing by 20 weeks; 61% of patients receiving an experimental agent had total healing compared with 39% of placebo-treated patients. Linear regression suggested that all patients would achieve total healing by 37 weeks. CONCLUSIONS: Since wound healing trajectories for diabetic foot ulcers treated at 2 centers so closely mimic one another, trajectories might be useful efficacy end points, and used to compare significant points along a continuum rather than a single static end point. Shifting of the wound healing trajectory from an impaired to a more ideal course may be considered when determining efficacy of new wound treatments.     

Determinants of Success After Metatarsal Head Resection for the Treatment of Neuropathic Diabetic Foot Ulcers

Metatarsal head resection (MHR) is an effective option for the treatment of nonhealing neuropathic diabetic foot ulcers. The present study aimed to identify factors that predict treatment success for neuropathic diabetic foot ulcers undergoing metatarsal head resection. In this prospective interventional case series, 30 consecutive diabetic patients with documented nonischemic neuropathic plantar diabetic foot ulcers beneath the metatarsal head who underwent MHR were included. The study endpoint was demographic indicators of early and late postoperative outcomes. Patients were followed up for 1 to 66 months (mean 37.6 months). Except for 1 patient, all subjects’ wounds (96.6%) healed after metatarsal head resection within an average of 35 days. One of the operated patients (3.4%) suffered short-term complications; long-term complications occurred in 23.3% of the patients. One patient (3.4%) experienced ulcer recurrence, 3 patients (10%) developed wound infection, and transfer lesions occurred in 3 other patients (10%) during the follow-up period. Using 3 estimators including ordinary least squares (OLS), White's heteroscedastic standard errors, and bootstrapping procedure, we could not find any statistically significant demographic feature related to ulcer healing. Using regression modeling, we could not find any evidence for a role of age, sex, weight, height, BMI, duration of ulcer until MHR, and duration of diabetes mellitus (years since diabetes diagnosis) affecting the outcome of MHR. Hence, demographic features, duration of ulcer until MHR, and years with diabetes did not affect the outcome of MHR. In conclusion, the authors believe that MHR will have a high rate of success for neuropathic wound healing in this specific subset of patients regardless of demographic features, as long as there is no ischemia to impair healing by secondary intention.     

High-valve vapor-permeable film dressing versus fine mesh gauze dressing on skin graft donor areas in diabetic patients: a prospective randomized controlled trial

The use of split-thickness skin grafts (STSG) as a reconstructive technique in the diabetic foot is common. Studies on the ideal dressing for donor-site care have not included subjects such as diabetics who have wound-healing problems. The aim of this study was to determine the efficacy of high-valve water vapor transmission rate (WVTR) polyurethane film dressing in the management of the STSG donor site compared to the clinical standard fine mesh gauze dressing in diabetic patients. Twenty diabetic patients were observed for healing, scarring, and pain. Healing times were recorded. Pain was monitored using a visual analog pain scale and recorded. Scarring of the donor sites was assessed using the Vancouver scar scale 6 months after surgery. The WVTR dressing was found to be significantly better than mesh gauze dressing for the healing of STSG donor sites. Healing occurred more rapidly and with less pain. Moreover, it has some advantages of dry wound dressings such as ease of application and follow-up. Dressings should retain enough moisture to stimulate good healing and yet should not cause maceration to the surrounding skin, and also should not cause allergic reactions. In this study it was shown that high-valve WVTR polyurethane film dressing provided many qualities of the ideal split-thickness skin graft donor-site dressing.     

Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: an initial experience

The purpose of this study was to evaluate outcomes of persons with UT grade 2A neuropathic diabetic foot wounds treated with an acellular matrix. Data were abstracted for 17 consecutive patients with diabetes--76.5% males, aged 61.5 +/- 8.5 years with a mean glycated haemoglobin of 9.2 +/- 2.2% presenting for care at a large, multidisciplinary wound care centre. All patients received surgical debridement for their diabetic foot wounds and were placed on therapy consisting of a single application of an acellular matrix graft (GraftJacket; Wright Medical Technologies, Arlington, TN, USA) with dressing changes taking place weekly. Outcomes evaluated included time to complete wound closure and proportion of patients achieving wound closure in 20 weeks. Acellular matrix therapy was used as initial therapy and was sutured or stapled in place under a silicone-based non adherent dressing. Therapy was then followed by a moisture-retentive dressing until complete epithelialisation. In total, 82.4% of wounds measuring a mean 4.6 +/- 3.2 cm(2) healed in the 20-week evaluation period. For those that healed in this period, healing took place in a mean 8.9 +/- 2.7 weeks. We conclude that a regimen consisting of moist wound healing using an acellular matrix dressing may be a useful adjunct to appropriate diabetic foot ulcer care for deep, non-infected, non-ischaemic wounds. We await the completion of further trials in this area to confirm or refute this initial assessment.     

Treatment of diabetic foot ulcers using cultured allogeneic keratinocytes—A pilot study

Diabetic foot ulcers often pose a difficult treatment problem. Repeated applications of cell‐based products have been reported to result in acceleration of diabetic wound healing. The purpose of this clinical trial study was to report preliminary findings of the efficacy and safety of the cultured allogeneic keratinocyte sheets in the treatment of diabetic foot ulcers. Fifty‐nine patients with diabetic foot ulcers were randomized to either the keratinocyte treatment group (n = 27) or the control group treated with vaseline gauze (n = 32). Except for the application of keratinocytes, treatment of study ulcers was identical for patients in both groups. Either keratinocyte sheet or vaseline gauze was applied at the beginning of the study and weekly thereafter for a maximum of 11 weeks. The maximum follow‐up period for each patient was 12 weeks. Complete ulcer healing was achieved in 100% of the treatment group and 69% of the control group (p < 0.05). The Kaplan–Meier median times to complete closure were 35 and 57 days for the keratinocyte and control groups, respectively. No adverse events related to the treatment occurred. These results indicate that cultured allogeneic keratinocytes may offer a safe and effective treatment for diabetic foot ulcers.     

Cost consequences due to reduced ulcer healing times – analyses based on the Swedish Registry of Ulcer Treatment

Resource use and costs for topical treatment of hard‐to‐heal ulcers based on data from the Swedish Registry of Ulcer Treatment (RUT) were analysed in patients recorded in RUT as having healed between 2009 and 2012, in order to estimate potential cost savings from reductions in frequency of dressing changes and healing times. RUT is used to capture areas of improvement in ulcer care and to enable structured wound management by registering patients with hard‐to‐heal leg, foot and pressure ulcers. Patients included in the registry are treated in primary care, community care, private care, and inpatient hospital care. Cost calculations were based on resource use data on healing time and frequency of dressing changes in Swedish patients with hard‐to‐heal ulcers who healed between 2009 and 2012. Per‐patient treatment costs decreased from SEK38 223 in 2009 to SEK20 496 in 2012, mainly because of shorter healing times. Frequency of dressing changes was essentially the same during these years, varying from 1·4 to 1·6 per week. The total healing time was reduced by 38%. Treatment costs for the management of hard‐to‐heal ulcers can be reduced with well‐developed treatment strategies resulting in shortened healing times as shown in RUT.     

A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non-healing diabetic foot ulcers

The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with non-healing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days(95% CI:24.3–58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device-related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non-healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.     

Initial multi‐centre observations upon the effect of a new topical negative pressure device upon patient and clinician experience and the treatment of wounds

Topical Negative Pressure (TNP) has become an accepted intervention in wound healing with a growing body of scientific literature supporting the effectiveness of TNP across a wide variety of wound aetiologies. The range of TNP devices has also increased with perhaps the primary distinction being between those TNP devices that employ gauze or foam as a wound dressing. This study reports preliminary multi‐centre observations upon the use of a new gauze based TNP device in the treatment of wounds. Across 3 study centres twenty‐nine subjects were recruited to the study with 8 presenting with leg ulcers, 8 with pressure ulcers, 12 with acute or surgical wounds and 1 with a non‐healing burn injury. Wounds were then treated with the new TNP therapy for a maximum of 17 days (range 2–17 days). There appeared to be a trend for subjects with leg ulcers to be treated for longer (mean duration 12.9 days) compared to subjects with pressure ulcers (mean duration 6.5 days) or those with surgical wounds (mean duration 8.2 days). Given the relatively short duration of the TNP therapy no wound completely healed although 22/29 (75.9%) showed reductions in surface area per day of treatment with all but 1 pressure ulcer and 1 leg ulcer responding positively to treatment. While not an RCT, this and similar cohort studies may be central to the future selection of TNP devices given the increasing importance of the role of the user interface to reduce the likelihood of incorrect use and sub‐optimal outcomes.