The efficacy of topical royal jelly on healing of diabetic foot ulcers: a double‐blind placebo‐controlled clinical trial

Foot ulcers are major sources of morbidity in individuals with diabetes mellitus. As royal jelly (RJ, a worker honey bee product) contains enzymatic, antibacterial and vasodilative properties, it can potentially help in healing of diabetic foot ulcers (DFUs). This study aimed to evaluate the efficacy of topical RJ on healing of DFUs. Diabetic patients with foot ulcers who were referred to us at Khorshid Hospital, Isfahan, Iran, were managed by offloading, infection control, vascular improvement and debridement (if required). Then, all ulcers were randomly selected to receive either 5% sterile topical RJ or placebo on their total surface area. Patients were followed for 3 months or until complete healing. Twenty‐five patients (6 females and 19 males) and a total of 64 ulcers were included and randomly allocated to case or control group (32 per group). Four ulcers were excluded and 60 ulcers included in the final analysis. Healing parameters including depth, length and width reduction rate, duration of complete healing and incidence of complete healing did not show any significant difference (P = 0·69, 0·95, 0·7, 0·74 and 0·6, respectively) between groups. We did not observe any side effect of topical RJ application. This study could not confirm any significant superiority of 5% topical RJ over placebo for the treatment of DFUs.     

Characteristics of a large cohort of patients with diabetes having at‐risk feet and outcomes in patients with foot ulceration referred to a tertiary care diabetes unit

To identify in a large population cohort the clinical and biochemical characteristics of patients with diabetes at risk of foot ulceration and outcomes in those with foot ulcers. All patients with diabetes attending Baqai Institute of Diabetology and Endocrinology from January 2004 to April 2012 included in the study. Clinical, biochemical and socio‐demographic data were collected and patients were categorised into those at no risk of ulceration, at risk of ulceration and those with foot ulcer, according to the University of Texas classification. Patients with foot ulceration followed for their final outcome, that is complete healing, persisted non‐healed ulcer, lower extremity amputation, lost to follow‐up or death. A total of 18 119 patients with diabetes underwent assessment, 3576 (19·7%) patients defined as at high risk for foot ulceration and 3731 (20·6%) presented with foot ulcer. Age, male gender, hypertension, higher glycated haemoglobin (HbA1c), history of smoking and presence of neuropathy were risk factors (P < 0·000) for foot ulceration. Amputation rate in patients with foot ulceration was significantly related to severity of ulceration at presentation. Preventive foot care practices were followed by 19·02% patients. One thousand eight hundred seventy three (50·2%) patients completely healed, 293 (11%) patients underwent amputation and 397 (10·1%) patients continued to be treated in the foot clinic. All patients with diabetes should be screened for neuropathy to identify those at risk of foot ulceration, as it is the major contributory factor for foot ulceration. The final outcome of foot ulceration was determined by the severity and grade of ulcer at presentation.     

A multi‐centre,single‐blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers

Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective of this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla, Missouri) compared with a standard of care group (SOC, collagen alginate dressing) at 12 weeks. Both groups received standard diabetic foot care including glucose monitoring, weekly debridements when needed and an offloading device. The primary endpoint was proportion of full‐thickness, non‐infected, non‐ischaemic wounds healed at 12 weeks, with secondary endpoints including percent area reduction (PAR) and changes in Semmes‐Weinstein monofilament testing. The result illustrated in the intent‐to‐treat analysis at 12 weeks showed that 70% (14/20) of the BBGFM‐treated DFUs healed compared with 25% (5/20) treated with SOC alone (adjusted P = .006). Mean PAR at 12 weeks was 79% in the BBGFM group compared with 37% in the SOC group (adjusted P = .027). Mean change in neuropathic score between baseline and up to 12 weeks of treatment was 2.0 in the BBGFM group compared with −0.6 in the SOC group where positive improvement in scores are better (adjusted P = .008). The mean number of BBGFM applications was 6.0. In conclusion, adding BBGFM to SOC significantly improved wound healing with no adverse events related to treatment compared with SOC alone.     

Education in people with venous leg ulcers based on a brochure about compression therapy: A quasi‐randomised controlled trial

Brochures are a useful supplement to patient education. There is increasing evidence that they are an effective medium to support patient satisfaction, adherence, and empowerment. This study aims to produce reliable data on how much patients with venous leg ulcer (VLU) may profit from a brochure that focuses on VLU and on measures and aims of the related compression therapy. The evaluation took part from October 2018 until March 2019 and included 136 patients with VLU and related compression therapy. They were randomly sorted into a case group and a control group of 68 patients each. The case group received a brochure about venous disease and compression therapy and filled in a questionnaire after reading. The questions ranged from basic knowledge about VLU and compression therapy to aspects of self‐care. The control group answered the same questions without previous reading of the brochure. The results show that in almost every aspect, the patients in the case group were better informed about their diseases, the compression therapy, and how they may support the measures adequately. This study suggests that patients with VLU may profit from a brochure that explains their disease and the related compression therapy. Better knowledge and understanding may strengthen their empowerment and adherence.     

A multicentre,randomised controlled clinical trial evaluating the effects of a novel autologous,heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard-of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States. Twenty-three subjects underwent the autologous heterogeneous skin construct harvest and application procedure once; two subjects required two applications due to loss of the first application. The primary endpoint was the proportion of wounds closed at 12 weeks. There were significantly more wounds closed in the treatment group (18/25; 72%) vs controls (8/25; 32%) at 12 weeks. The treatment group achieved significantly greater percent area reduction compared to the control group at every prespecified timepoint of 4, 6, 8, and 12 weeks. Thirty-eight adverse events occurred in 11 subjects (44%) in the treatment group vs 48 in 14 controls (56%), 6 of which required study removal. In the treatment group, there were no serious adverse events related to the index ulcer. Two adverse events (index ulcer cellulitis and bleeding) were possibly related to the autologous heterogeneous skin construct. Data from this planned interim analysis support that application of autologous heterogeneous skin construct may be potentially effective therapy for DFUs and provide supportive data to complete the planned study.     

Non‐contact low‐frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single‐centre,assessor‐blinded,randomised controlled trial

‘Hard‐to‐heal’ wounds are those which fail to heal with standard therapy in an orderly and timely manner and may warrant the use of advanced treatments such as non‐contact low‐frequency ultrasound (NLFU) therapy. This evaluator‐blinded, single‐site, randomised controlled trial, compared NLFU in addition to UK standard of care [SOC: (NLFU + SOC)] three times a week, with SOC alone at least once a week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomised patients completed treatment (17 NLFU + SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU + SOC patients showed a −47% (SD: 38%) change in wound area; SOC, −39% (38%) change; and difference, −7·4% [95% confidence intervals (CIs) −33·4–18·6; P = 0·565]. The median number of infections per patient was two in both arms of the study and change in quality of life (QoL) scores was not significant (P = 0·490). NLFU + SOC patients reported a substantial mean (SD) reduction in pain score of −14·4 (14·9) points, SOC patients' pain scores reduced by −5·3 (14·8); the difference was −9·1 (P = 0·078). Results demonstrated the importance of high‐quality wound care. Outcome measures favoured NLFU + SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow‐up may reveal NLFU‐related improvements not identified in this study.     

Differences in the daily activity of patients with diabetic foot ulcers compared to controls in their free‐living environments

The aims of our study were to investigate multiple daily activity outcomes in patients with diabetic foot ulcers (DFU) compared to diabetic peripheral neuropathy (DPN) and diabetes (DM) controls in their free‐living environments. We examined daily activity outcomes of 30 patients with DFU, 23 DPN and 20 DM. All patients wore a validated multi‐sensor device for > 5 days (>22 hours per day) to measure their daily activity outcomes: steps, energy expenditure (kJ), average metabolic equivalent tasks (METs), physical activity (>3·0 METs) duration and energy expenditure, lying duration, sleep duration and sleep quality. We found that DFU patients recorded fewer median (interquartile ranges, IQR) daily steps [2154 (1621–4324)] than DPN [3660 (2742–7705)] and DM [5102 (4011–7408)] controls (P < 0·05). In contrast, DFU patients recorded more mean ± SD daily energy expenditure (kJ) (13 006 ± 3559) than DPN (11 085 ± 1876) and DM (11 491 ± 1559) controls (P < 0·05). We found no other differences in daily activity outcomes (P > 0·1). We conclude that DFU patients typically take fewer steps but expend more energy during their normal daily activity than DPN and DM controls. We hypothesise that the increased energy expenditure for DFU patients may be due to wound healing or an inefficient gait strategy. Further investigations into this energy imbalance in DFU patients may improve healing in future.     

Perceptions and experiences of diabetic foot ulceration and foot care in people with diabetes: A qualitative meta‐synthesis

Diabetic foot ulceration (DFU) is a common and debilitating complication of diabetes that is preventable through active engagement in appropriate foot‐related behaviours, yet many individuals with diabetes do not adhere to foot care recommendations. The aim of this paper was to synthesise the findings of qualitative papers exploring diabetic people's perceptions and experiences of DFU in order to identify how they could be better supported to prevent ulceration or manage its impact. Five databases (MEDLINE, PsycINFO, CINAHL, EMBASE, Web of Science) were searched in May 2016 to identify eligible articles. Findings were synthesised using a meta‐ethnographic approach. Forty‐two articles were eligible for inclusion. Synthesis resulted in the development of five overarching themes: personal understandings of diabetic foot ulceration; preventing diabetic foot ulceration: knowledge, attitudes, and behaviours; views on health care experiences; development of diabetic foot ulceration and actions taken; and wide‐ranging impacts of diabetic foot ulceration. The findings highlight various barriers and facilitators of foot care experienced by people with diabetes and demonstrate the significant consequences of ulcers for their physical, social, and psychological well‐being. The insights provided could inform the development of interventions to promote foot care effectively and provide appropriate support to those living with ulceration.     

Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective,randomised, multicentre study

This 12‐week, prospective, randomised, controlled multi‐centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix (AM) (study group) and standard of care (control group) therapies. Eighty‐six patients were randomised into study (47 patients) and control (39 patients) groups. No significant differences in demographics or pre‐treatment ulcer data were calculated. Complete healing and mean healing time were 69·6% and 5·7 weeks, respectively, for the study group and 46·2% and 6·8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant (P = 0·0289), with odds of healing in the study group 2·7 times higher than in the control group. Kaplan–Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate (P = 0·015) for the control group (53·9%) compared with the study group (30·4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate (P = 0·0194), a statistically significant difference in non healing rate between groups was calculated (P = 0·0233), with odds of healing 2·0 times higher in the study versus control group. This study supports the use of single‐application AM therapy as an effective treatment of diabetic, neuropathic ulcers.     

A prospective,multicentre, randomised controlled study of human fibroblast‐derived dermal substitute (Dermagraft) in patients with venous leg ulcers

This was an open‐label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast‐derived dermal substitute (HFDS) plus four‐layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12 weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty‐four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P = 0·235). For ulcers ≤ 12 months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12 weeks (P = 0·029). For ulcers ≤ 10 cm², complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P = 0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.     

The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi‐centre,controlled, randomised,blinded, clinical trial

In a randomised, controlled study, we compared the efficacy of Grafix^®, a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.     

Multi‐centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers

Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non‐healing DFUs of which 50 were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Misonix,Inc., Farmingdale, NY) compared with 50 subjects treated with standard of care (SOC, collagen alginate dressing) at 12 weeks. Both groups received standardised care that included glucose monitoring, weekly debridement''s as appropriate, and an offloading device. The primary endpoint was proportion of full‐thickness wounds healed at 12 weeks, with secondary endpoints including differences in percent area reduction (PAR) at 12 weeks, changes in Semmes‐Weinstein monofilament score, VAS pain, and w‐QoL. The result illustrated in the intent‐to‐treat analysis at 12 weeks showed that 76% (38/50) of the BSA‐treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). Mean PAR at 12 weeks was 77.8% in the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In conclusion, adding BSA to SOC appeared to significantly improve wound healing with a lower incidence of adverse events related to treatment compared with SOC alone.     

Human amniotic membrane allograft,a novel treatment for chronic diabetic foot ulcers: A systematic review and meta‐analysis of randomised controlled trials

To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta‐analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: −30.33 days, [95% CI: −37.95, −22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.     

The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind,randomised controlled pilot study

Recent reviews suggest that amniotic membrane products may accelerate healing of diabetic foot ulcers. A new dried human amniotic membrane (dHAM) has been used for ocular ulcers but not for diabetic foot ulcers. This was a multi‐centre, prospective, patient and observer blind, randomised controlled pilot trial, to investigate whether 2 weekly addition of the dHAM to standard care versus standard care alone increased the proportion of healed participants'' index foot ulcers within 12 weeks. Thirty‐one people (mean age 59.8 years, 81% male, 87% type 2 diabetes) were randomised (15 dHAM, 16 usual care). Within 12 weeks, healing occurred in 4 (27%) ulcers in the dHAM group versus 1 (6.3%) usual care group (P = .1). Percentage wound area reduction was higher in the dHAM versus control group. (P = .0057). There was no difference in AEs between the two groups. Six participants allocated to dHAM correctly identified their treatment group, although 5 in usual care incorrectly thought they were in the intervention arm. This pilot trial result is encouraging showing that this dHAM preparation is safe and promising treatment. These results will be used to design a statistically powered, definitive double blind randomised controlled trial.     

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.     

An exploratory clinical study on the safety and efficacy of an autologous fibroblast‐seeded artificial skin cultured with animal product‐free medium in patients with diabetic foot ulcers

Cultured dermal substitutes have been used for the treatment of chronic skin ulcers; however, the biological risks of animal‐derived materials in the culture process such as foetal bovine serum (FBS) have been reported. In this study, we prepared an autologous fibroblast‐seeded artificial dermis (AFD) using animal‐product‐free medium supplemented with 2% patient autologous serum and without any animal‐derived materials such as trypsin in the culturing process. We applied the AFD in five patients with diabetic ulcers and investigated its safety and efficacy. As the primary endpoint, we defined ‘wound bed improvement' according to the percentage of granulation area to the whole wound area on day 21, and 60% or higher was regarded as improved. The mean age of the patients was 60·6 years and the mean duration of the ulcer was 22·6 months. In the evaluation of the primary endpoint, the ‘wound bed’ was improved in all patients [proportion of improvement: 100%, 95% confidence interval (CI): 48% to 100%]. Three patients had complete wound healing within 12 weeks after application and two patients had >80% wound healing at 12 weeks. Side effects were not serious. Our AFD may be a safe and effective treatment of diabetic ulcers.     

Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi‐centre clinical trial with a microvascular tissue allograft

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single‐blinded, multi‐centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub‐studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P = .0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P = .009), decreased time to healing (54 days vs 64 days; P = .009), and improved local neuropathy (118% vs 11%; P = .028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub‐studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non‐healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.     

The effectiveness of a four‐layer compression bandage system in comparison with Class 3 compression hosiery on healing and quality of life in patients with venous leg ulcers: a randomised controlled trial

An increasing number of compression systems available for treatment of venous leg ulcers and limited evidence on the relative effectiveness of these systems are available. The purpose of this study was to conduct a randomised controlled trial to compare the effectiveness of a four‐layer compression bandage system and Class 3 compression hosiery on healing and quality of life (QL) in patients with venous leg ulcers. Data were collected from 103 participants on demographics, health, ulcer status, treatments, pain, depression and QL for 24 weeks. After 24 weeks, 86% of the four‐layer bandage group and 77% of the hosiery group were healed (P = 0·24). Median time to healing for the bandage group was 10 weeks, in comparison with 14 weeks for the hosiery group (P = 0·018). The Cox proportional hazards regression found participants in the four‐layer system were 2·1 times (95% CI 1·2–3·5) more likely to heal than those in hosiery, while longer ulcer duration, larger ulcer area and higher depression scores significantly delayed healing. No differences between groups were found in QL or pain measures. Findings indicate that these systems were equally effective in healing patients by 24 weeks; however, a four‐layer system may produce a more rapid response.     

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.     

Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open‐label,single‐arm feasibility study in diabetic foot ulcers

Diabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging the endogenous repair capabilities of the patient's healthy skin. The AHSC's ability to close DFUs with a single treatment was evaluated in an open‐label, single‐arm feasibility study. Eleven patients with DFUs extending up to tendon, bone, or capsule received a single topical application of AHSC. Closure was documented weekly with high‐resolution digital photography and wound planimetry. All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time‐to‐complete closure was 25 days. The mean percent area reduction for all 11 wounds at 4 weeks was 83%. There were no adverse events related to the AHSC treatment site. This pilot study demonstrated AHSC may be a viable single application topical intervention for DFUs and warrants investigation in larger, controlled studies.