The effect of frailty on management of diabetic foot ulcers: Comparative effectiveness of two matrices products – a randomized controlled trial

Treatment strategies based on use of dermal matrices for management of chronic wounds has dramatically increased during the past two decades (1). Factors such as frailty may impact the pro-inflammatory state of wounds decreasing the activity of regeneration (2). This randomized controlled trial examined the effect of frailty on success of wound granulation with a human acellular dermal matrix (DM)* and a bilayer bovine dermal matrix (BLM) †.

Patients with chronic diabetic wounds ≥ Grade 2 Wagner class were randomized (n=1:1) to receive either DM or BLM matrices. Wounds were biweekly monitored for a 4-month period or until successfully closed. Primary outcome was percentage of granulation at the end of the study. Frailty status was evaluated using a validated trauma-specific frailty index (FI) questionnaire. Generalized linear model was used for analysis. The study was registered in Clinicaltrials.gov-Identifier:  NCT03476876.

Twenty-nine patients (DM= 58.6% vs BLM= 41.4%; age: 58±16, 75.8% male, 55% frail) were recruited and 18 completed the study. There were no significant differences for baseline demographics and clinical characteristics between groups. Overall, baseline HbA1c showed a significant correlation with frailty status (p=0.05). Successful granulation was significantly higher among non-frails than frails (56% for non-frails v. 11% for frails, p=0.02). Results also showed a trend of enhanced granulation for DM compared to BLM for frails (73% for DM v. 48% for BLM, p=0.24), while BLM trends to do better for non-frails (87% for BLM v. 73% for DM, p=0.63). However, the trends did not achieve statistical significant level in our sample.

To our knowledge, this is the first study suggesting that success of acellular matrices might depend on frailty status and thus, different materials could be selected to optimize outcome. This observation should be validated in a larger sample size.
 

Trademarked Items (if applicable): * DermACELL human acellular dermal matrix (LifeNet, USA)
† Integra bilayer bovine dermal matrix (Integra LifeSciences Corp., USA).

References (if applicable): 1. Frykber R, et al. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015; 4(9): 560–582.
2. Qian-LI Xue. The Frailty Syndrome: Definition and Natural History. Clin Geriatr Med. 2011 (27): (1-15)