A preliminary clinical evaluation using a novel bioengineered wound product to treat lower extremity ulcers

Diabetes mellitus has become a global pandemic, with ~422 million people affected worldwide, including 29 million people in the US [1, 2]. Patients with diabetes have may have up to a 25% lifetime risk of developing a diabetic foot ulcer (DFU) [3].  Currently, the standard of care (SOC) for initial treatment of DFUs is debridement, offloading, tight glycemic control and appropriate antimicrobial management and/or imaging when needed [4]. A meta-analysis of patients studied in controlled trials demonstrated, on average, healing rates of 31% at 20 weeks with SOC [5]. In cases where a wound fails to decrease in size by 50% within 4 weeks with SOC, advanced levels of care are initiated to attempt to close the wound and limit these complications [6].
The objective of this preliminary study was to evaluate lower extremity ulcers treated with a novel bioengineered wound product (BWP)*. The BWP, a solid absorbable and conformable sheet comprised of gelatin, Manuka honey, and hydroxyapatite, was applied on 12 patients with lower extremity ulcers. Wounds were treated with debridement, placement of the product, dressing, appropriate compression, and offloading as necessary. Weekly follow-up visits were recommended for evaluation, debridement, and product reapplication as necessary. The primary evaluation endpoint was wound closure over time.
Nine patients had the BWP applied to aid in full wound closure. These patients achieved 100% closure within eight weeks, with a mean closure time of 4.1 weeks. At four weeks, the mean percent wound closure was 94%. Two patients had the product applied to aid in achieving a healthy wound bed for continued treatment (e.g. application of a split thickness skin graft) and in one patient the product was used to achieve epithelialization over an exposed tendon. In all 12 cases, no treatment site infections were observed. Further clinical studies are needed, however, observations from this preliminary study suggest that the novel bioengineered wound product supports rapid wound closure, which is a predictor of complete healing for lower extremity ulcers.

Trademarked Items (if applicable): *APIS®, SweetBio, Inc., Memphis, TN

References (if applicable): 1-6: NCD-RisC 2016; CDC 2014; Singh 2005; Doupis 2008; Margolis 1999; Sheehan 2003