An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial

Abstract

Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR‐ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty‐eight percent (27/40) in the HR‐ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR‐ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft‐related adverse events. The mean and median HR‐ADM product costs at 12 weeks were $1200 and $680, respectively. HR‐ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non‐healing diabetic foot ulcers.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review

“…A significantly higher ulcer healing rate at weeks 16 and 24 was observed of the intervention ADM (I: 70.0% vs C: 49.3%; OR 1.589, P = .044), but this was a per‐protocol analysis . Another study of aseptically processed human reticular ADM (HR‐ADM) of 80 patients assessed the proportion of ulcers closed at 6 weeks compared with a standard care group receiving daily collagen alginate dressing changes . It reported a significantly higher rate of healing (I: 80% vs C: 30%) as well as lower mean time to heal with the intervention, but the study was not blinded and was considered to be at a moderate risk of bias especially as an interim analysis of the same cohort had previously been published …”

The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials

“…After reading the full texts, 36 articles were excluded, three of them were duplicate studies [16][17][18], one of them was a conference abstract without available full text [19], while the other one only included 6 patients in the control group [20]. Finally, 9 RCTs were eligible for this metaanalysis [21][22][23][24][25][26][27][28][29]. Table 1.…”

“…Figure 2. All studies were described as RCTs, of which 5 studies [24,[26][27][28][29] clearly described the method of random sequence generation and 2 studies [26,28] reported allocation concealment. Although the blinding method of participants and personnel were not mentioned in 3 studies [22,23,27], all 9 studies were assessed as having a high risk of performance bias, as AM was easily to be identified during the application by the study staff.…”

“…Although the blinding method of participants and personnel were not mentioned in 3 studies [22,23,27], all 9 studies were assessed as having a high risk of performance bias, as AM was easily to be identified during the application by the study staff. Blinding of outcome assessment was reported in only 4 of the studies [21,26,28,29], and most studies were considered to have a low risk of attrition bias and reporting bias. Figure 1: Flow chart of the study selection.…”

“…(3) Complete Healing Rate at 6 Weeks and 28 Weeks. Only 3 studies [22,27,28] involving 154 patients reported the incidence of complete healed ulcers in 6 weeks, with 77 patients randomized to each group. No significant differences existed between the two groups (RR = 2:62, 95% CI: 0.88 to 7.84, P = 0:08; I 2 = 84%; Figure 5).…”