Application of a collagen matrix dressing on a neuropathic diabetic foot ulcer: a randomised control trial

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Gholamreza Esmaeeli Djavid 1, Seyed Mehdi Tabaie 1, Siamak Bashardoust Tajali 2, Mehrangiz Totounchi 1, Amirreza Farhoud 3, Mohsen Fateh 1, Mahmoud Ghafghazi 4, Mojtaba Koosha 5, Solmaz Taghizadeh

Main idea: The collagen matrix dressing used in this study accelerated the healing process of patients with a hard-to-heal diabetic foot ulcer. Further research may suggest the used of this dressing to shorten the length of time to achieve complete healing.

Abstract

Objective: Diabetic foot ulcers (DFU) are often hard-to-heal, despite standard care. With such a complicated healing process, any advanced wound care to aid healing is recommended. Chitosan/collagen composite hydrogel materials have the potential to promote the regenerative process. In this study, the efficacy of a new collagen matrix dressing including chitosan/collagen hydrogel was compared with a standard dressing of saline-moistened gauze for wound healing in patients with a hard-to-heal neuropathic DFU.

Method: This is an open labelled, randomised clinical trial. After conventional therapy consisting of debridement, infection control and offloading, patients were randomly allocated to receive either a collagen matrix dressing (the study group, receiving Tebaderm manufacturer) or a saline-moistened gauze dressing (control group) for wound care. The reduction in DFU size and the number of patients with complete healing were measured throughout the treatment and in follow-up.

Results: A total of 61 patients with a neuropathic DFU were recruited. Average percentage reduction in diabetic foot ulcers size at four weeks was greater in the study group compared with the control group (54.5% versus 38.8%, respectively). Rate of complete healing rate at 20-weeks’ follow-up was significantly better in the study group than the control group (60% versus 35.5%, respectively).

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