Pilot Trial of Biovance Collagen-Based Wound Covering for Diabetic Ulcers

Letendre, Serena; LaPorta, Guido A.; O'Donnell, Elaine; Dempsey, Jennifer C.; Léonard, Karen

doi:10.1097/01.asw.0000305463.32800.32

Cited by 18 publications

(16 citation statements)

References 6 publications

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“…Letendre et al74 described the application of Biovance (Celgene Cellular Therapeutics, Morris, New Jersey) is a decellularized, dehydrated human amniotic membrane proposed to have collagen matrix and fibroblastic properties indicated for the management of noninfected partial- and full-thickness wounds. The purpose of this study was to determine healing rates for partial- or full-thickness diabetic foot ulcers treated with Biovance over a 12-week period.…”

Section: Discussionmentioning

confidence: 99%

Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review

Holmes¹,

Wrobel²,

MacEachern³

et al. 2013

DMSO

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BackgroundDiabetic foot ulcers are a major source of morbidity, limb loss, and mortality. A prolonged inflammatory response, extracellular matrix degradation irregularities, and increased bacteria presence have all been hypothesized as major contributing factors in the delayed healing of diabetic wounds. Collagen components such as fibroblast and keratinocytes are fundamental to the process of wound healing and skin formation. Wound dressings that contain collagen products create a biological scaffold matrix that supports the regulation of extracellular components and promotes wound healing.MethodsA systematic review of studies reporting collagen wound dressings used in the treatment of Diabetic foot ulcers was conducted. Comprehensive searches were run in Ovid MEDLINE, PubMed, EMBASE, and ISI Web of Science to capture citations pertaining to the use of collagen wound dressings in the treatment of diabetic foot ulcers. The searches were limited to human studies reported in English.ResultsUsing our search strategy, 26 papers were discussed, and included 13 randomized designs, twelve prospective cohorts, and one retrospective cohort, representing 2386 patients with diabetic foot ulcers. Our design was not a formal meta-analysis. In those studies where complete epithelialization, 58% of collagen-treated wounds completely healed (weighted mean 67%). Only 23% of studies reported control group healing with 29% healing (weighted mean 11%) described for controls.ConclusionCollagen-based wound dressings can be an effective tool in the healing of diabetic foot wounds. The current studies show an overall increase in healing rates despite limitations in study designs. This study suggests that future works focus on biofilms and extracellular regulation, and include high risk patients.

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Section: Discussionmentioning

confidence: 99%

Collagen-based wound dressings for the treatment of diabetes-related foot ulcers: a systematic review

Holmes¹,

Wrobel²,

MacEachern³

et al. 2013

DMSO

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“…Fourteen patients with chronic refractory DFUs sized from 1 to 49 cm 2 were enrolled in a pilot open label study. 66 Nine patients who completed the 12-week study without deviations were included in the analysis. By week 12, 55.5% of patients (5/9) closed their wounds, 33.3% (3/9) showed wound size reduction of > 50%, and 11.1% (1/9) had < 50% wound size reduction.…”

Section: Commercial Placental Membrane Productsmentioning

confidence: 99%

Use of Placental Membranes for the Treatment of Chronic Diabetic Foot Ulcers

Brantley

Verla

2015

Advances in Wound Care

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Significance: Chronic diabetic foot ulcers (DFUs) remain a challenge for physicians to treat. High mortality rates for DFU patients have pointed to the low effectiveness of standard care and lack of quality wound care products. The composition (collagen-rich tissue matrix and endogenous growth factors and cells) and functional properties (anti-inflammatory, anti-bacterial, and angiogenic) of placental membranes are uniquely suited to address the needs of chronic wounds. This led to the commercialization of placental membranes, which are now widely available to physicians as a new advanced wound treatment option.Recent Advances: Progress in tissue processing and preservation methods has facilitated the development of placental products for wounds. Currently, a variety of commercial placental products are available to physicians for the treatment of chronic DFUs and other wounds. This review summarizes the key factors that negatively impact DFU healing (including social factors, such as smoking, vascular deficiencies, hyperglycemia, and other metabolic abnormalities), describes the structure and biology of placental membranes, and overviews commercially available placental products for wounds and data from the most recent DFU clinical trials utilizing commercial placental membranes.Critical Issues: Although the effects of diabetes on wound healing are complex and not fully understood, some of the key factors and pathways that interfere with healing have been identified. However, a multidisciplinary approach for the assessment of patients with chronic DFUs and guidelines for selection of appropriate treatment modalities remain to be implemented.Future Directions: The biological properties of placental membranes show benefits for the treatment of chronic DFUs, but scientific and clinical data for commercially available placental products are limited. Therefore, we need (1) more randomized, controlled clinical trials for commercial placental products; (2) studies that help to understand the timing of placental products' application and criteria for patient selection; and (3) studies comparing the functional properties of different commercially available placental products.

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“…10,18,20,21,23,29 They are also being used for several foot and ankle applications, such as diabetic foot ulcerations and other types of chronic wounds. 15,34,36 Although this study was randomized, controlled, and double-blind, there are several limitations that need to be addressed. First, the sample size was lower than initially intended.…”

Section: Foot and Ankle Internationalmentioning

confidence: 99%