Related Experiment Video
Updated: Jan 21, 2026

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep
Shawn Cazzell1, Peter M Moyer, Brian Samsell
1Shawn Cazzell, DPM, FAPWCA, FAPWH, is Chief Medical Officer, Limb Preservation Platform, Fresno, California. Peter M. Moyer, DPM, FACFAS, AAPWCA, is Podiatrist, Purvis Moyer Foot and Ankle Center, Rocky Mount, North Carolina. At LifeNet Health, Virginia Beach, Virginia, Brian Samsell, BS, is Scientific Writer; Kimberly Dorsch, BS, CCRP, CRCP, is Director of Global Clinical Affairs; Julie McLean, PhD, is Senior Manager of Scientific Affairs; and Mark A. Moore, PhD, is Global Senior Director of Scientific Affairs. Acknowledgments: The authors thank Collin Smith for data analysis support. This study was funded by LifeNet Health, a nonprofit organization that processes the studied acellular dermal matrix. Dr Cazzell and Dr Moyer were among the clinical trial investigators for this study and received research funding. Mr Samsell, Ms Dorsch, Dr McLean, and Dr Moore are employees of LifeNet Health. All patient outcomes were evaluated solely by the investigators to minimize potential for bias. The authors have disclosed no other financial relationships related to this article. Submitted January 3, 2019; accepted in revised form March 8, 2019; published online ahead of print, July 9, 2019.
Objective:
This prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone.
Methods:
Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested. Ulcers were assessed weekly for 16 weeks using a laser measuring device.
Results:
Sixty-one participants were enrolled, with an average wound area of 29.0 cm; 59 of these ulcers showed exposed bone. The entire per-protocol population (n = 47) achieved 100% granulation. The mean time to 100% granulation was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound area reduction was 80.3% at 16 weeks. Those DFUs 15 cm or smaller were substantially more likely to close than DFUs larger than 29 cm (P = .0008) over a 16-week duration. No complications were associated with the use of the studied matrix.
Conclusions:
The D-ADM demonstrated the ability to rapidly reduce the size of large, complex DFUs with exposed bone. Some wounds did not completely heal by 16 weeks; however, the significant reduction in size suggests that these large, complex wounds may heal if given more time.
More Related Videos
03:07Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
14:45Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Drugs for Treatment of Ulcerative Colitis in IBD
Statistical Software for Data Analysis and Clinical Trials
Peptic Ulcer Disease III: Clinical Manifestations and Diagnostic Studies
Few clinical manifestations differentiate gastric ulcers from duodenal ulcers. Distinctions in the location, timing, and pain relief are crucial for healthcare providers in differentiating between gastric and duodenal ulcers during clinical assessments.
Muscles of the Leg that Move the Foot and Toes
Anterior Compartment
The anterior compartment includes muscles that contribute to the dorsiflexion of the foot. This compartment houses the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles....