Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)

Diabetic Foot Clinical Trial

Official title: A Multi-center, Prospective Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)

Status Not yet recruiting

Clinical Trial Summary

This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs.

After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.

The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.

Clinical Trial Description

This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs.

After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.

The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.

The Screening Phase consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria, treatment.

At the Screening Visit (SV), written informed consent is obtained from the subject by the Investigator or designee prior to the performance of any other protocol-specific procedure.

At the SV, 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 may transition to Treatment Visit 1 (TV1) on the same day as the SV or at a later date.

The Treatment Phase (12 Weeks) Subjects who meet eligibility criteria at the SV will receive HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.

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 HaM. 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. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

• NCT number: NCT05198544
• Study type: Interventional
• Source: SerenaGroup, Inc.
• Contact: Thomas Serena, MD, FACS
• Phone: 814-688-4000
• Email: serena@serenagroups.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: December 31, 2023