Diabetic Foot Ulcers (DFUs) Clinical Trial
Official title:
A Multi-center, Prospective Clinical Trial Evaluating the Effect of Meso Wound Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs).
This is a prospective trial designed to evaluate the use of Meso Wound Matrix (DSM Biomedical, Exton, PA) in Wagner grade 1 and 2 DFUs.
At the Screening Visit (SV), written informed consent will be obtained from the subject by the Investigator or designee before the performance of any other protocol-specific procedure. The Investigator will select the Index (study) ulcer. Each subject will have only one DFU selected as the Index (study) ulcer. If the subject has more than one ulcer at the SV, the Investigator will select the largest ulcer that meets the eligibility criteria of the protocol as the Index (study) ulcer.The SV is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. Those subjects who meet the eligibility criteria will transition to Treatment Visit 1 (TV1) on the same day as the SV. Subjects who meet eligibility criteria at the SV will receive Meso Wound Matrix (DSM Biomedical, Exton, PA) and standard of care. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects may receive up to eight applications of Meso Wound Matrix. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks. Subjects whose ulcers do not achieve closure at or by 12 weeks or who experience an amputation will be deemed treatment failures. ;