Evaluation of wound healing of diabetic foot ulcers in a prospective clinical trial using a synthetic hybrid-scale fiber matrix

Abstract

Chronic diabetic foot ulcers (DFUs) often experience inadequate healing rates, and alternatives to existing therapies are needed to improve the success of wound healing. The objective of this clinical study (clinicaltrials.gov number NCT03312595) was to evaluate outcomes using a synthetic hybrid-scale fiber matrix for the treatment of DFUs. Methods: In this prospective multi-center clinical study, chronic DFUs were treated with the synthetic matrix. Postapplication, wounds were examined weekly for wound progression and tissue healing for up to 12 weeks. Results: Twenty-four patients with DFUs completed the study and were included in the analysis. At the end of the 12-week treatment period, 18 of 24 wounds (75%) reported complete wound closure. The average reduction in wound surface area over 12 weeks was 96% ± 10%. For the wounds that healed, the average time to complete wound closure was 6.4 ± 2.5 weeks. The synthetic matrix resulted in significant healing of chronic non-healing DFUs unresponsive to at least one previous advanced wound care modality. The incidence of complete healing in the present study was observed to be notably greater than standard care methods and comparable to other advanced wound therapies. Conclusions: The findings suggest that the hybrid-scale fiber matrix may be a viable alternative to existing wound care modalities for the treatment of chronic DFUs.

Treatment of Hematomas Using a Synthetic Hybrid-Scale Fiber Matrix

“…Additional clinical studies utilizing the synthetic hybrid-scale fiber matrix have resulted in 75% complete wound closure rate of recalcitrant neuropathic foot ulcers (three of four wounds) after 13 to 28 weeks [10] and a 75% wound closure rate of diabetic foot ulcers (18 of 24 wounds) with an average time to complete closure being 6.4 weeks [12].…”

“…The efficacy of the synthetic hybrid-scale fiber matrix observed here is similar to findings in clinical studies of other wound types treated with the synthetic matrix, including an 85% complete wound closure rate of chronic lower extremity wounds (68 of 82 wounds) at 12 weeks after initial application [ 9 ] and a 96% wound closure rate of lower extremity wounds (22 of 23 wounds) with an average time to heal of 96.1 days [ 11 ]. Additional clinical studies utilizing the synthetic hybrid-scale fiber matrix have resulted in 75% complete wound closure rate of recalcitrant neuropathic foot ulcers (three of four wounds) after 13 to 28 weeks [ 10 ] and a 75% wound closure rate of diabetic foot ulcers (18 of 24 wounds) with an average time to complete closure being 6.4 weeks [ 12 ].…”

“…Preclinical assessment in a porcine wound healing model found that the synthetic hybrid-scale fiber matrix demonstrated superior healing quality and an accelerated rate of healing compared to a bilayer xenograft matrix, including faster collagen deposition, neovascularization, granulation tissue formation, and wound closure [8]. Clinical application of the synthetic matrix has also demonstrated significant wound healing across multiple wound types, including recalcitrant foot ulcers, venous leg ulcers, diabetic foot ulcers, and pressure ulcers [9][10][11][12].…”

Clinical Evaluation of a Synthetic Hybrid-Scale Matrix in the Treatment of Lower Extremity Surgical Wounds

“…This engineered design encourages cellular ingrowth, differentiation, and neovascularization [3]. The synthetic hybrid-scale fiber matrix has been applied to various types of wounds with positive outcomes [5][6][7][8][10][11][12]. Additionally, previous work has demonstrated economic benefits of the product compared with biologics, including cost savings associated with less operating room time, less operative time, lower total cost of care, and indirect cost savings associated with advantages resulting from the handling, storage, and preparation benefits [7].…”

“…Specifically, the synthetic hybrid-scale fiber matrix is an optimal solution due to its biocompatibility (composed of FDA-approved synthetic polymers, polyglactin 910, and polydioxanone) and fibrous structure with high porosity similar to the native extracellular matrix [3]. Successful clinical applications of this synthetic matrix have been shown in lower extremity wounds such as chronic neuropathic foot ulcers as well as in trauma and acute care wounds [5][6][7][8][9][10][11][12]. This retrospective case series evaluates the use of the synthetic hybrid-scale fiber matrix for the treatment of lower extremity wounds resulting from various types of amputations, such as transmetatarsal, metatarsal/partial ray, and Lisfranc amputations.…”