Efficacy and safety of autologous whole blood clot in diabetic foot ulcers: a randomised controlled trial.

OBJECTIVE: Diabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current available treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluated the safety and efficacy of a novel autologous whole blood clot (AWBC)-a blood-based, biodegradable provisional matrix-in conjunction with standard of care (SoC) when compared to SoC alone in the treatment of hard-to-heal DFUs. METHOD: A multicentre, prospective, blinded assessor, randomised controlled trial was conducted at 16 sites across the US, South Africa and Turkey. A cohort of patients with hard-to-heal DFUs was enrolled and randomised to either the AWBC group or the control group. The primary endpoint was complete wound closure at 12 weeks, while secondary endpoints included time to heal and percentage area reduction (PAR) at four and eight weeks. Data were analysed using both intention-to-treat (ITT) and per-protocol (PP) populations. RESULTS: The cohort included 119 patients. AWBC treatment resulted in a significantly higher healing rate compared to the control in both ITT (41% versus 15%, respectively; p=0.002) and PP populations (51% versus 18%, respectively; p=0.0075). AWBC treatment also resulted in a shorter mean time to heal and higher durability of wound closure. Safety analysis showed a similar incidence of adverse events (AEs) between groups, with no device-related AEs. CONCLUSION: The AWBC system, by modulating the wound microenvironment and providing a functional extracellular matrix, offered a promising new approach to treating hard-to-heal DFUs, demonstrating superior healing outcomes compared to SoC alone in this study.

Wound Bed Preparation 2024: Delphi Consensus on Foot Ulcer Management in Resource-Limited Settings.

GENERAL PURPOSE: To review a practical and scientifically sound application of the wound bed preparation model for communities without ideal resources. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and registered nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will:1. Summarize issues related to wound assessment.2. Identify a class of drugs for the treatment of type II diabetes mellitus that has been shown to improve glycemia, nephroprotection, and cardiovascular outcomes.3. Synthesize strategies for wound management, including treatment in resource-limited settings.4. Specify the target time for edge advancement in chronic, healable wounds.

Chronic wound management in low-resource settings deserves special attention. Rural or underresourced settings (ie, those with limited basic needs/healthcare supplies and inconsistent availability of interprofessional team members) may not have the capacity to apply or duplicate best practices from urban or abundantly-resourced settings. The authors linked world expertise to develop a practical and scientifically sound application of the wound bed preparation model for communities without ideal resources. A group of 41 wound experts from 15 countries reached a consensus on wound bed preparation in resource-limited settings. Each statement of 10 key concepts (32 substatements) reached more than 88% consensus. The consensus statements and rationales can guide clinical practice and research for practitioners in low-resource settings. These concepts should prompt ongoing innovation to improve patient outcomes and healthcare system efficiency for all persons with foot ulcers, especially persons with diabetes.

Management of Nonhealable and Maintenance Wounds: A Systematic Integrative Review and Referral Pathway.

GENERAL PURPOSE: To synthesize the evidence regarding nonhealable and maintenance wound management and propose an interprofessional referral pathway for wound management. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES: After participating in this continuing professional development activity, the participant will apply knowledge gained to:1. Identify the ideas from the authors' systematic review that could prove useful in understanding nonhealable and maintenance wound management.2. Select evidence-based management strategies for nonhealable and maintenance wound management. ABSTRACT: OBJECTIVEThis systematic integrative review aims to identify, appraise, analyze, and synthesize evidence regarding nonhealable and maintenance wound management to guide clinical practice. An interprofessional referral pathway for wound management is proposed. DATA SOURCES: An electronic search of Scopus, Web of Science, PubMed, Academic Search Ultimate, Africa-Wide Information, Cumulative Index of Nursing and Allied Health Literature database with Full Text, Health Source: ConsumerEdition, Health Source: Nursing/Academic Edition, and MEDLINE was conducted for publications from 2011 to 2019. Search terms included (nonhealable/nonhealing, chronic, stalled, recurring, delayed healing, hard-to-heal) and wound types most associated with nonhealable or maintenance wounds. Published studies were hand searched by the authors. STUDY SELECTION: Studies were appraised using two quality appraisal tools. Thirteen reviews, six best-practice guidelines, three consensus studies, and six original nonexperimental studies were selected. DATA EXTRACTION: Data were extracted using a coding framework including treatment of underlying causes, patient-centered concerns, local wound care, alternative outcomes, health dialogue needs, challenges within resource restricted contexts, and prevention. DATA SYNTHESIS: Data were clustered by five wound types and local wound bed factors; further, commonalities were identified and reported as themes and subthemes. CONCLUSIONS: Strong evidence on the clinical management of nonhealable wounds is limited. Few studies describe outcomes specific to maintenance care. Patient-centered care, timely intervention by skilled healthcare providers, and involvement of the interprofessional team emerged as the central themes of effective management of maintenance and nonhealable wounds.

This systematic integrative review aims to identify, appraise, analyze, and synthesize evidence regarding nonhealable and maintenance wound management to guide clinical practice. An interprofessional referral pathway for wound management is proposed. An electronic search of Scopus, Web of Science, PubMed, Academic Search Ultimate, Africa-Wide Information, Cumulative Index of Nursing and Allied Health Literature database with Full Text, Health Source: Consumer Edition, Health Source: Nursing/Academic Edition, and MEDLINE was conducted for publications from 2011 to 2019. Search terms included (nonhealable/nonhealing, chronic, stalled, recurring, delayed healing, hard-to-heal) and wound types most associated with nonhealable or maintenance wounds. Published studies were hand searched by the authors. Studies were appraised using two quality appraisal tools. Thirteen reviews, six best-practice guidelines, three consensus studies, and six original nonexperimental studies were selected. Data were extracted using a coding framework including treatment of underlying causes, patient-centered concerns, local wound care, alternative outcomes, health dialogue needs, challenges within resource restricted contexts, and prevention. Data were clustered by five wound types and local wound bed factors; further, commonalities were identified and reported as themes and subthemes. Strong evidence on the clinical management of nonhealable wounds is limited. Few studies describe outcomes specific to maintenance care. Patient-centered care, timely intervention by skilled healthcare providers, and involvement of the interprofessional team emerged as the central themes of effective management of maintenance and nonhealable wounds.

The Ears of a Hippopotamus: Quality of Venous Leg Ulcer Care in Gauteng, South Africa.

OBJECTIVE: To describe venous ulcer care and wound care practices in Gauteng, a province of South Africa, according to the Donabedian structure-process-outcome quality improvement model. METHODS: Forty-eight facilities were selected randomly from public and private wound care practices in Gauteng. Structured interviews were conducted with care providers via questionnaire to assess the structural aspects of the Donabedian model. Within these facilities, investigators randomly selected 160 patient files and extracted data using a checklist to assess processes implemented and outcomes reached for patients who had previously presented with lower-leg venous ulcers. RESULTS: Facilities lack the necessary equipment to perform vital assessments. Handheld Dopplers were available in 66% (n = 48) of the facilities. Sixty-one percent (n = 48) of the personnel at the facilities indicated that they had no formal wound care training. Although the majority of files (92%, n = 147) indicated that an assessment tool was used, many elements were not evaluated comprehensively according to the best available evidence. Aspects such as smoking, body mass index, and anemia were assessed in fewer than 30% of the patients. Distinguishing between superficial and deep infection and the accompanying overuse of antimicrobials and antibiotics were among the challenges identified. Further, 71% of patients received compression therapy, although the ankle-brachial pressure index of only 30% of patients was known. In 27 cases (17%), the outcome was amputation. CONCLUSIONS: From this survey, it is evident that not all clinicians providing wound care in Gauteng are adequately trained or fully implementing best practice guidelines, and the consequences are detrimental to patients, particularly in terms of amputation. This article highlights the need for improved legislation and regulation for practitioners who deliver wound care services.