A prospective, multicentre, open ‐label, single‐arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane

We report the results of a prospective, multicentre, open‐label, single‐arm clinical trial to establish clinical outcomes when vCHPM is applied weekly to complex DFUs with exposed deep structures. Patients with type 1 or type 2 diabetes and a complex DFU extending through the dermis with evidence of exposed muscle, tendon, fascia, bone and/or joint capsule were eligible for inclusion. Of the 31 patients enrolled, 27 completed the study. The mean wound area was 14·6 cm2, and mean duration was 7·5 months. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96·3% of patients in a mean of 6·8 weeks. Complete wound closure occurred in 59·3% (mean 9·1 weeks). The 4‐week percent area reduction was 54·3%. There were no product‐related adverse events. Four patients (13%) withdrew, two (6·5%) for non‐compliance and two (6·5%) for surgical intervention.
Source: International Wound Journal - Category: Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research