Clinical trials: Foot Ulcers, Diabetic
Diabetic Foot Ulcer (DFU)
A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers
The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers.
- Trial name
- AIM-DFU (NCT07783087)
- Testing
- VES-0-D wound gel, Standard of Care (Investigator Choice)
- Where
- 8 sites in Belgium
- Volunteers
- 64 people
- Sponsor
- Flen Health
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
Diabetic Foot Ulcer (DFU)
CARE-D-FOOT-Nav Pilot
This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).
- Trial name
- NCT07143175
- Testing
- Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Emory University
Diabetic Foot Ulcer (DFU), Granulation of Chronic Diabetic Wounds
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue.
- Trial name
- NCT07498218
- Testing
- an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix, Standard of Care of Diabetic Foot Ulcers
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Ayu, Inc.
Diabetic Foot Ulcers (DFUs)
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3.
- Trial name
- NCT07565506
- Testing
- Antimicrobial agent
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Lakewood-Amedex Inc
Diabetic Foot Ulcer
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot…
- Trial name
- REBOUND (NCT06420245)
- Testing
- Orion TM Amniotic Membrane Allograft, Standard of Care (SOC)
- Where
- 8 sites in United States
- Volunteers
- 240 people
- Sponsor
- Legacy Medical Consultants
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer (DFU)
Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care
This is a prospective, multicentre, randomized clinical trial evaluating the safety, tolerability, and efficacy of up to 12 weeks treatment with SoC + low- or high-dose CYWC628 in treating DFU, compared to SoC only.
- Trial name
- NCT07096934
- Testing
- Standard of Care (SOC), SoC + Low dose CYWC628, SoC + High dose CYWC628
- Where
- 9 sites in Australia
- Volunteers
- 120 people
- Sponsor
- FibroBiologics
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer (DFU), Palliative Care
The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care
The ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU).
- Conditions
- Diabetic Foot Ulcer (DFU), Palliative Care, Advance Care Planning
- Trial name
- NCT07781111
- Volunteers
- 484 people
- Sponsor
- Ulla Riis Madsen
Diabetic Foot Ulcer
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers.
- Trial name
- NCT05519501
- Testing
- Syntrfuge Microfragmented Fat, Standard of Care
- Volunteers
- 62 people
- Sponsor
- Syntr Health Technologies, Inc.
Diabetic Foot Ulcers (DFUs)
PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
This study is designed to evaluate topical wound products for DFUs using a hybrid design that combines prospectively randomized treatment arms with external control cohorts.
- Trial name
- NCT07779239
- Testing
- Bonvadis® (NWBOT), Clostridial Collagenase Ointment
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
- Trial name
- ELITE (NCT07014176)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- 8 sites in United States
- Volunteers
- 84 people
- Sponsor
- Cellution Biologics
Diabetes Mellitus, Foot Ulcer
Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation.
- Trial name
- NCT05415878
- Testing
- RCW design form
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rosalind Franklin University of Medicine and Science
Diabetic Foot Ulcer
At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers
Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer.
- Trial name
- NCT06312579
- Testing
- 12-week home based exercise, 12-week standard of care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- VA Office of Research and Development
Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.
Primary outcome: To evaluate the efficacy of L-Carnitine supplementation on length and depth ulcer size Secondary outcome: To investigate the effect of L-Carnitine supplements on: 1. Vascular endothelial growth factor (VEGF) 2.
- Trial name
- NCT07768228
- Testing
- L- carnitine
- Where
- 2 sites in Egypt
- Volunteers
- 50 people
- Sponsor
- Ain Shams University
Diabetic Foot Ulcer
Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team.
- Trial name
- NCT04058639
- Testing
- "custom felt relief", standard relief treatment
- Where
- Norway
- Volunteers
- 74 people
- Sponsor
- Helse Møre og Romsdal HF
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Trial name
- FOCUS 3D (NCT07632001)
- Testing
- Miro3D Wound Matrix, Standard of Care
- Where
- 14 sites in United States
- Volunteers
- 180 people
- Sponsor
- Reprise Biomedical, Inc.
Non-infected Diabetic Foot Ulcer, Diabetic Foot
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Conditions
- Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound, Diabetic Foot Ulcer
- Trial name
- NCT06565156
- Testing
- BR-AM, Standard Care
- Where
- 17 sites in United States
- Volunteers
- 72 people
- Sponsor
- BioStem Technologies
Diabetic Ulcers on Both Feet
Nanotechnological Silver-Coated Dressing in Diabetic Foot Ulcers
Diabetic foot ulcers are the complication of diabetes most frequently requiring hospitalization and carry very high treatment costs.
- Trial name
- NANOSIL-DFU (NCT07758855)
- Testing
- Nanotechnological silver-coated wound dressing, Sterile saline-moistened gauze dressing
- Where
- Turkey (Türkiye)
- Volunteers
- 107 people
- Sponsor
- Ankara City Hospital Bilkent