SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

Clinical Trial Description

This study is a prospective, multi-center, randomized controlled trial (RCT) designed to assess the safety and efficacy of SkinTE with standard of care (SOC) dressings compared to SOC dressings alone (wound debridement, silicone dressing, multi-layer compression dressings, and offloading) in the treatment of Wagner grade 1 diabetic foot ulcers (DFUs) ranging in size from 1 to 15 cm2. After being informed about the study and potential risks, all patients giving written informed consent who meet eligibility criteria will undergo a 2-week screening period of SOC. Patients meeting eligibility criteria following the screening period will be randomized in a single-blind manner (closure confirmed by 3 blinded adjudicators) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06140303
Study type	Interventional
Source	PolarityTE
Contact	Ashlee Fishleigh
Phone	800-653-8031
Email	clinicalresearch@PolarityTE.com
Status	Not yet recruiting
Phase	Phase 3
Start date	February 2024
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06154915` - Immune Cells in Diabetic Chronic Foot Ulcers
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Completed	`NCT02373592` - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer	N/A
Active, not recruiting	`NCT01903044` - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating	Phase 1/Phase 2
Completed	`NCT02092870` - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds	Phase 2
Completed	`NCT01212120` - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections	N/A
Completed	`NCT00402727` - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection	Phase 3
Recruiting	`NCT04085705` - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Completed	`NCT04480801` - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer	N/A
Not yet recruiting	`NCT04537676` - Patient Empowerment Study
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A
Recruiting	`NCT05974592` - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program	N/A
Not yet recruiting	`NCT04630795` - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting	`NCT05431660` - Diabetic Foot School and Biomechanics	N/A
Completed	`NCT05101473` - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study	N/A
Completed	`NCT05123157` - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation	`NCT05043636` - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed	`NCT03254095` - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
Terminated	`NCT01657318` - Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers