To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial

Campitiello, Ferdinando; Mancone, Manfredi; Corte, A Della; Guerniero, Raffaella; Canonico, Silvestro

doi:10.1007/s13304-017-0461-9

Cited by 29 publications

(27 citation statements)

References 22 publications

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“…They also noted lower amputation and rehospitalization rates. 61 Hu et al compared split grafting with ADM with split grafting alone and found that, in the ADM group, recurrence rates were lower, and wound and scar appearance was better, but wound closure rates were similar in both groups. 62 DermACELL, an ADM that has undergone a unique decellularization process resulting in thorough DNA removal, was evaluated in two studies compared with conventional care and Graftjacket ADM.…”

Section: Acellular Bioproductsmentioning

confidence: 99%

Update on management of diabetic foot ulcers

Everett

Mathioudakis

2018

Annals of the New York Academy of Sciences

569

403

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Diabetic foot ulcers (DFUs) are a serious complication of diabetes that results in significant morbidity and mortality. Mortality rates associated with the development of a DFU are estimated to be 5% in the first 12 months, and 5-year morality rates have been estimated at 42%. The standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound off-loading, vascular assessment, and infection and glycemic control. These practices are best coordinated by a multidisciplinary diabetic foot wound clinic. Even with this comprehensive approach, there is still room for improvement in DFU outcomes. Several adjuvant therapies have been studied to reduce DFU healing times and amputation rates. We reviewed the rationale and guidelines for current standard of care practices and reviewed the evidence for the efficacy of adjuvant agents. The adjuvant therapies reviewed include the following categories: nonsurgical debridement agents, dressings and topical agents, oxygen therapies, negative pressure wound therapy, acellular bioproducts, human growth factors, energy-based therapies, and systemic therapies. Many of these agents have been found to be beneficial in improving wound healing rates, although a large proportion of the data are small, randomized controlled trials with high risks of bias.

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Section: Acellular Bioproductsmentioning

confidence: 99%

Update on management of diabetic foot ulcers

Everett

Mathioudakis

2018

Annals of the New York Academy of Sciences

569

403

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“…Two recent RCTs with topical Pirferidone (with potential anti‐inflammatory/antifibrotic properties) had methodological limitations; neither were blinded, results were analysed per protocol, and there was a high dropout rate in one, and an unexpectedly low healing rate in the control group in the other . Four RCTs of products designed to promote healing; Chitosan and Isosorbide dinitrate, hyaluronic acid, an acellular flowable matrix, and the proteolytic fraction from latex P1G10 provided little support for the use of these agents in clinical practice because of a small number of recruited patients, nonblinding, per protocol analysis, and/or high drop‐out rates. One RCT of a gap‐junctional protein (ACT1, a connexin43‐based gel) in patients with noninfected neuropathic ulcers showed a significantly greater reduction in mean percent ulcer area from baseline to 12 weeks but with a high rate of withdrawal of consent and protocol noncompliance …”

Section: Recommendationsmentioning

confidence: 99%

Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update)

Rayman

Vas

Dhatariya

et al. 2020

Diabetes Metabolism Res

166

183

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The International Working Group on the Diabetic Foot (IWGDF) has published evidence‐based guidelines on the prevention and management of diabetic foot disease since 1999. In conjunction with advice from internal and external reviewers and expert consultants in the field, this update is based on a systematic review of the literature centred on the following: the Population (P), Intervention (I), Comparator (C) and Outcomes (O) framework; the use of the SIGN guideline/Cochrane review system; and the 21 point scoring system advocated by IWGDF/EWMA. This has resulted in 13 recommendations. The recommendation on sharp debridement and the selection of dressings remain unchanged from the last recommendations published in 2016. The recommendation to consider negative pressure wound therapy in post‐surgical wounds and the judicious use of hyperbaric oxygen therapy in certain non‐healing ischaemic ulcers also remains unchanged. Recommendations against the use of growth factors, autologous platelet gels, bioengineered skin products, ozone, topical carbon dioxide, nitric oxide or interventions reporting improvement of ulcer healing through an alteration of the physical environment or through other systemic medical or nutritional means also remain. New recommendations include consideration of the use of sucrose‐octasulfate impregnated dressings in difficult to heal neuro‐ischaemic ulcers and consideration of the use of autologous combined leucocyte, platelet and fibrin patch in ulcers that are difficult to heal, in both cases when used in addition to best standard of care. A further new recommendation is the consideration of topical placental derived products when used in addition to best standard of care.

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“…The advanced wound matrix was well tolerated and in patients (13.04%) with graft failure had no clinical and/or laboratory inflammatory signs was observed [35].…”

Section: Short Commentarymentioning

confidence: 95%

A Short Commentary about Efficacy of an Flowable Matrix in the Treatment of Diabetic Foot Ulcers

Campitiello¹,

Mancone²,

A³

et al. 2017

Clin Res Foot Ankle

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The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra Life Science Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in sixty patients with diabetic foot ulcers (Grades 3 Wagner ulcer). A randomized clinical trial was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-seven cases of diabetic foot ulcers were equally and randomly divided into two groups: in a group treated with a wet dressing and expected closure by secondary intention; in another group the lesions were filled with Integra Flowable Wound Matrix and surgical wound edges were either approximated with stitches. The complete healing rate valued at 6 weeks, in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; P=0.001). Amputation and re-hospitalization rates were higher in the control group compared to Integra Flowable Wound Matrix group. Therefore, the difference was statistically significant.This new porous matrix, allows a closure for the first intention of the lesion by reducing healing time and the demolition surgery. An advanced wound matrix is not associated with side effects, is well tolerated. Ease of use, absence of adverse effects, and a minimal invasive approach by primary intention closure of the lesion, make it appropriate in the management diabetic foot ulcers.Keywords: Diabetic foot ulcers; Tunneling lesions; Biomaterial; Flowable matrix Short CommentaryPatients with diabetes can develop many different foot complications. Even ordinary injures can get worse and lead to serious complications. Without early and optimal intervention, the wound can rapidly deteriorate, leading to amputation of the affected limb. A diabetic foot ulcer is a critical event in the life of a person with diabetes and is one of the complications of diabetes that can cause life threatening. Diabetic foot ulcers have a major economic impact as well; data have shown diabetic foot ulcers (DFUs) are a major cause of hospitalization for patients with diabetes.

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To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial

Cited by 29 publications

References 22 publications

Update on management of diabetic foot ulcers

Update on management of diabetic foot ulcers

Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update)

A Short Commentary about Efficacy of an Flowable Matrix in the Treatment of Diabetic Foot Ulcers

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