Clinical Research

To discuss how patient considerations and the initial wound environment can affect wound treatment and summarize the way in which the initial US Wound Registry measures capture aspects of the DIME (Debridement/devitalized tissue, Infection or inflammation, Moisture balance, and wound Edge preparation/wound depth) principles. The treatment of chronic wounds often involves extended hospital stays and long-term outpatient follow-up visits with costly advanced therapeutic interventions. As complex care is required for chronic wounds, treatment guidelines such as DIME have evolved to include consideration of patient-centered concerns and etiology, as well as features of wound bed preparation. The US healthcare system is in the midst of transitioning to a quality-based system. However, as wound care is not yet a recognized specialty, it is poorly represented in the current approved quality-based measures. This article helps to identify the practice guidelines that are not currently repres...

An advisory panel of academicians, private practice physicians, podiatrists, nurse clinicians, research nurses, industrial scientists, and an epidemiologist was chosen to develop guidelines for the treatment of venous ulcers of the lower extremity. METHODS Previous guidelines, meta-analyses, PubMed, MEDLINE, EMBASE, The Cochrane Database of Systematic Reviews, recent review articles of venous ulcer treatment, and the Medicare/CMS consensus of usual treatment of chronic wounds were all reviewed for evidence. Guidelines were formulated, the underlying principle(s) enumerated, and evidence references listed and coded. The code abbreviations for the evidence citations were as follows: STAT Statistical analysis, meta analysis, consensus statement by commissioned panel of experts RCT Randomized clinical trial LIT REV Literature review CLIN S Clinical case series RETRO S Retrospective series review EXP Experimental laboratory or animal study TECH Technique or methodology description PATH S Pathological series review

Too many wound care research studies are poorly designed, badly executed, and missing crucial data. The objective of this study is to create a series of principles for all stakeholders involved in clinical or comparative effectiveness research in wound healing. The Delphi approach was used to reach consensus, using a web-based survey for survey participants and face-to-face conferences for expert panel members. Expert panel (11 members) and 115 wound care researchers (respondents) drawn from 15 different organizations. Principles were rated for validity using 5-point Likert scales and comments. A 66% response rate was achieved in the first Delphi round from the 173 invited survey participants. The response rate for the second Delphi round was 46%. The most common wound care researcher profile was age 46-55 years, a wound care clinic setting, and >10 years' wound care research and clinical experience. Of the initial 17 principles created by the panel, only four principles were not endorsed in Delphi round 1 with another four not requiring revision. Of the 14 principles assessed by respondents in the second Delphi round, only one principle was not endorsed and it was revised; four other principles also needed revision based on the use of specific words or contextual use. Of the 19 final principles, three included detailed numbered lists. With the wide variation in design, conduct, and reporting of wound care research studies, it is hoped that these principles will improve the standard and practice of care in this field.

The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92⋅5% (37/40) ulcers completely healed. Mean time to complete healing was 4⋅1 ± 2⋅9 versus 2⋅4 ± 1⋅8 weeks (P = 0⋅039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0⋅014). Number of grafts applied to healed wounds was similar at 2⋅4 ± 1⋅5 and 2⋅3 ± 1⋅8 for biweekly versus weekly groups, respectively (P = 0⋅841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications.

Proteases have various roles in wound healing such as the migration and activation of fibroblasts, extra cellular matrix remodelling and growth factor activation. However, in some non-healing chronic wounds, protease activity remains at an elevated level which impairs wound healing and can lead to chronic inflammation .The impact of elevated protease activity on wound healing is being discussed more frequently clinically and the need to control these proteases is being considered in the selection of treatment for chronic wounds.

Background : We sought to develop a consensus statement for the use of off-loading in the management of diabetic foot ulcers (DFUs). Methods : A literature search of PubMed for evidence regarding off-loading of DFUs was initially conducted, followed by a meeting of authors on March 15, 2013, in Philadelphia, Pennsylvania, to draft consensus statements and recommendations using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to assess quality of evidence and develop strength of recommendations for each consensus statement. Results : Evidence is clear that adequate off-loading increases the likelihood of DFU healing and that increased clinician use of effective off-loading is necessary. Recommendations are included to guide clinicians on the optimal use of off-loading based on an initial comprehensive patient/wound assessment and the necessity to improve patient adherence with off-loading devices. Conclusions : The likelihood of DFU healing is i...

A rare case report of Aggressive Digital Adenocarcinoma (ADPCa) is presented complete with a literature review encompassing lesions that pose potential diagnostic challenges. Similarities between basal cell carcinoma (BCC), marjolin's ulceration/squamous cell carcinoma (MSCC) and ADPCa are discussed. This article discusses potential treatment options for ADPCa and the need for early biopsy when faced with any challenging lesion. An algorithmic approach to ADPCa treatment based on the most current research is recommended.

Pyoderma gangrenosum (PG) is an uncommon chronic and progressive skin disorder that can lead to severe tissue necrosis, pathergy, horrendous pain, and disfigurement if not properly and promptly diagnosed and treated. Systemic treatment traditionally consists of long-term immunosuppression. Topical care of the painful wound often represents a clinical challenge. A 77-year-old woman with multiple comorbidities including venous insufficiency and diabetes mellitus was diagnosed through exclusion with refractory, painful PG. She was managed for 3 months by a multidisciplinary team comprised of an internist, 2 dermatologists, and a podiatric wound care specialist using immunosuppressive therapy, several local wound care modalities, and supportive bandages. During that time, severe wound pain continued unabated and the affected area changed from 3 separate wounds measuring 1.4 cm x 1.0 cm x .01 cm, 1.2 cm x 0.5 cm x 0.1 cm, and 0.6 cm x 0.5 cm x 0.1 cm to 1 wound measuring 8.0 cm x 10.3 cm x 0.1 cm. At that time, dehydrated human amnion/ chorion membrane (dHACM) allograft, previously reported to facilitate healing venous leg and diabetic foot ulcers, was incorporated into the treatment plan. The patient reported wound pain decreased from 10 out of 10 to 5 out of 10 within hours following application. At the 4 day follow-up visit, she reported no pain; after 1 week, the wound decreased 6.4 cm x 9.4 cm x 0.1 cm in size and after 2 months (3 applications) the wound had reduced in area from 103 cm 2 to 57.96 cm 2 (reduced by more than half [56%]). In this patient, following the application of dHACM as an adjunct to immunosuppressive therapy, pain receded and wound healing commenced. Additional controlled studies are needed to ascertain the generalizability of this observation.

The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9%; p=0.008; mPP: 59.5% versus 35.6%; p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. Conclusions: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone. Declaration of interest: This study has been fully sponsored by Integra LifeSciences Inc., manufacturer of PriMatrix®, a fetal bovine acellular dermal matrix. JCL is a paid consultant of Integra LifeSciences. RS, DV and LAL receive consultancy fees from Integra. The authors have no other conflicts of interest to declare.

Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared ...

Objective: To investigate the efficacy of focused extracorporeal shockwave therapy (ESWT) as an adjunctive treatment for neuropathic diabetic foot ulcers (DFU) (1A or 2A on the University of Texas grading scheme), compared with sham treatment. Method: We performed two multicentre, randomised, sham-controlled, double-blinded, phase III clinical trials using focused ESWT compared with sham examining DFUs that did not reduce in volume by ≥50% over 2 weeks' standard treatment immediately prior to randomisation. Patients were enrolled into the trials and randomised for either standard care and focused ESWT (pulsed acoustic cellular expression. dermaPACE System, SANUWAVE Health Inc.) active therapy, or standard care and sham therapy. Both active and sham therapy were administered four times in 2 weeks in study 1 and a maximum of eight times over 12 weeks in study 2. Standard care continued in both studies throughout the 12-week treatment phase. The proportion of DFUs that closed compl...

Healthcare systems are being challenged to manage increasing numbers of nonhealing wounds. Wound dressings are one of the first lines of defense in wound management, and numerous options exist. The oxidized regenerated cellulose (ORC)/collagen dressing may offer healthcare providers a robust and cost-effective tool for use in a variety of wounds. A multidisciplinary panel meeting was convened to discuss the use of ORC/collagen dressings in wound care and provide practice recommendations. A literature search was conducted to provide a brief review of the peer-reviewed studies published between January 2000 and March 2016 to inform the meeting. A 2-day panel meeting convened in February 2017. Healthcare providers with experience using ORC/collagen dressings. This multidisciplinary panel of 15 experts in wound healing included podiatrists, wound care specialists (doctors, certified wound care nurses, and research scientists), and an orthopedist. The literature search identified 58 arti...