Advances in Wound Care

To verify the noninferiority of the effectiveness of “semiocclusive dressing” (SOD) treatment using plastic wrap or low-adherent absorbent wound dressings compared with occlusive dressing (OD) treatment for National Pressure Injury Advisory Panel stage II pressure injuries.

This 12-week, open-label, randomized, controlled, noninferiority trial was conducted at one hospital and three care facilities. Of the 115 participants, 56 were assigned to SOD treatment and 59 to OD treatment. The study design adhered to the CONSORT 2010 extension statement for noninferiority trials. The primary outcome was a comparison of the healing times for both treatments, with the noninferiority margin set at 7.0 days. Secondary outcomes included treatment costs, Kaplan–Meier curves, and incidence of adverse events.

The mean healing times for SOD and OD treatments were 19.7 and 22.5 days, respectively (p = 0.4175). The 95% confidence interval of the difference was –4.0 to 9.6. Since its lower limit was within the noninferiority margin, SOD treatment was confirmed to be not significantly worse than OD treatment. OD treatment had a significantly higher mean cost than SOD treatment (p < 0.0001). Kaplan–Meier curves for both groups were similar (p = 0.249). The incidence of adverse events in both groups was comparable.

Uniquely, the SOD does not tightly adhere to or completely occlude the wound and can manage abundant exudate. Therefore, SOD treatment maintains an adequately moist environment to facilitate wound healing.

SOD treatment was more cost-effective than OD treatment for stage II pressure injuries.

Platform studies are an innovative clinical trial design to evaluate multiple potential therapies simultaneously using a master protocol framework for more rapid discovery of critical new disease-modifying therapies. Initially pioneered in cancer clinical trials, platform studies have more recently been adopted for new vaccine trials and other disease states. This approach has not been used for biomarker(s) validation.

We present the development and successful implementation of a master protocol for a platform study in the National Institute of Diabetes and Digestive and Kidney Diseases Diabetic Foot Consortium (DFC) that concomitantly tests multiple biomarkers that could be used to predict diabetic foot ulcer (DFU) healing outcomes in people with DFUs.

This flexible master protocol, allowing the study of multiple biomarkers in a perpetual manner, designed to be inclusive of a broad spectrum of people with DFUs operating under the mantra “No DFU Goes Unstudied” successfully collects participant data and biospecimens for biomarker development and validation in a standardized manner across multiple DFC sites.

Integrating multiple biomarkers with a rich database of participants’ clinical characteristics, patient-reported outcomes, and standard of care practices at various sites collected longitudinally over 52 weeks following a pragmatic approach and thus relevant to people with DFU as seen in today’s daily practice, enable their subsequent implementation at the point of care to guide timely personalized DFU management decisions.

Leveraging this robust platform will help to identify new therapeutic targets and design and conduct effective interventional clinical trials for DFU wound healing, which could inform the standards of care.

Diabetic foot ulcers (DFUs) remain one of the most devastating complications of diabetes, accounting for over 80% of nontraumatic amputations and contributing to a 5-year mortality rate exceeding 30%. Despite significant clinical advances, profound disparities persist. Racial and ethnic minoritized populations, rural communities, and people with low socioeconomic resources experience disproportionate rates of severe ulceration, infection, delayed healing, and amputation.

Traditional research approaches, often developed in academic settings without community input, have insufficiently addressed the contextual, cultural, and structural factors shaping DFU risk and outcomes.

Community-engaged research (CEnR) offers a promising pathway to address these inequities; yet, DFU-specific evidence remains limited and heterogeneous. In response, the Diabetic Foot Consortium (DFC), a national research network funded by the National Institute of Diabetes and Digestive and Kidney Diseases, has initiated multisite efforts to embed community advisory boards, faith-based partnerships, mobile outreach, and culturally aligned engagement into DFU research.

We propose the DFC-CEnR Model, a conceptual framework for integrating community-engaged approaches to DFU prevention, early detection, treatment, and research participation. The model distinguishes CEnR from related approaches (community-based participatory research, patient and public involvement, cultural humility, and equity-focused system interventions), outlining hypothesized mechanisms and evaluation domains. Illustrative consortium examples demonstrate how engagement domains may be operationalized and inform future testing of validated outcome measures.

This article positions community engagement as a hypothesis-generating strategy that requires rigorous empirical testing to determine its impact on DFU outcomes and disparities.

The Wound Healing Foundation recognized the need for consensus-based unbiased recommendations for the treatment of wounds. Consensus statements on the treatment of chronic wounds and acute wounds have been developed and published previously. The current publication on diabetic wounds represents the next step in this process. Diabetic wounds constitute a major problem. Population-based and meta-analytic studies indicate that the presence of foot wounds in patients with diabetes increases their mortality risk by more than twofold. The management of diabetic wounds requires consistent and evidence-driven intervention to achieve optimal clinical outcomes. This consensus statement provides the clinician with the necessary foundational approaches to the causes, diagnosis, and therapeutic management of diabetic wounds. Presented in a structured format, this is a useful guide for clinicians and learners in all patient care settings.

Continuous glucose monitoring and other new tools have facilitated better diabetes management and the management of associated wounds. Diabetic limb salvage should focus on achieving and optimizing function for the patient with diabetes rather than preserving limb tissue at all costs.

Successful management of diabetic wounds requires a multidisciplinary approach encompassing comprehensive assessment, timely intervention, and collaborative care by the wound clinician with providers who can address critical aspects to achieve healing, including careful management of blood glucose levels, optimization of off-loading and physical therapy, assessment and treatment of limb ischemia, control and prevention of wound infection, and optimal pain management.

Emerging treatments offer hope and promise, but the heterogenicity of diabetic wounds poses a challenge to performing good studies, which will be necessary to advance new treatments for diabetic wounds.

Wound healing is a complex process, and while the epidermis and dermis receive significant attention, the role of the hypodermis is important. The adipose-rich hypodermis or subcutaneous layer supports overall skin function, and loss or injury can impair wound healing, result in adhesions and/or contracture, and restrict soft-tissue mobility. Traditional wound management methods are often insufficient for hypodermal injuries, necessitating innovative approaches.

Hypodermal adipose-based solutions, including fat grafting and stem cell therapies, show promise for reconstruction. Fat grafting enhances soft-tissue bulk and contour, enhances mechanical properties, and promotes angiogenesis, offering versatility in addressing a range of wound scenarios, including challenging cases. Adipose-derived stem cells exhibit regenerative potential, modulate inflammation, and facilitate tissue repair, making them valuable for scar revision, skin rejuvenation, and managing chronic wounds. Acellular adipose derivatives, such as exosomes and liquid extracts, contain bioactive molecules that support tissue regeneration and collagen production. Adipose-derived acellular extracellular matrix holds promise in wound healing by enhancing cell behavior and angiogenesis.

In this review, we will discuss adipose-centered options for improvement of wound healing and for restoration of the hypodermis together as a cluster of efficient and cost-effective wound management in cases of complex soft-tissue injuries.

These innovative therapies, while requiring further research, hold significant potential to simplify procedures, reduce costs, and improve the quality of life for patients facing challenging wounds.