Clinical trials: Non-healing Diabetic Foot Ulcer
Diabetic Foot Ulcer
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
The goal of this multi-center, randomized, controlled, evaluator-blinded study is to assess and measure the safety and efficacy of NOX1416 as an adjunct to standard of care (SOC) in the treatment of chronic, non-healing, diabetic…
- Trial name
- NTCDU (NCT06402565)
- Testing
- NOX1416 and SOC, SOC (Standard of care)
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- NOxy Health Products, LLC
Type2diabetes, Foot Ulcer
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care.
- Trial name
- NCT05603273
- Testing
- non-weight bearing exercise
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Diabetic Foot Ulcer
Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.
The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care
- Trial name
- NCT01816672
- Testing
- AutoloGel, Usual and Customary Care
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Cytomedix
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
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Foot Ulcer, Diabetic
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety.
- Trial name
- NCT05586542
- Testing
- DERMASEAL, Plasma Film, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Vitruvian Medical Devices, Inc.
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
Diabetic Foot Ulcer
VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers.
- Trial name
- DOLCE (NCT01450943)
- Testing
- SECONDARY dressing gauze and tape, debridement, irrigation, Dermagraft
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VA Office of Research and Development
Non-healing Wound, Non-healing Diabetic Foot Ulcer
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion…
- Conditions
- Non-healing Wound, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT03230175
- Testing
- TTAX01, Surgical resection and debridement, Systemic antibiotics
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- BioTissue Holdings, Inc
Foot Ulcers, Diabetic, Foot Ulcer Unhealed
SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds
Increasing prevalence of diabetes mellitus has led to increasing numbers of chronic non-healing foot ulcers (wounds). Electrolysed water is a novel antiseptic which reduces bacterial load and appears to encourage wound healing.
- Trial name
- SALACIA (NCT06908148)
- Testing
- Electrolysed water, Conventional irrigant
- Volunteers
- 200 people
- Sponsor
- NHS Lanarkshire
Diabetic Foot Ulcers, Diabetic Wound
The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin…
- Trial name
- NCT04315909
- Testing
- PRP-Fibrin Glue, Vitamin E and C
- Where
- Iran
- Volunteers
- 24 people
- Sponsor
- Mashhad University of Medical Sciences
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
Non-healing Wound, Diabetic Foot Ulcer
Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available self-assembling peptide, AC5®Advanced Wound…
- Trial name
- NCT06028386
- Testing
- AC5® Advanced Wound System, Fibracol Plus Collagen Dressing
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Arch Therapeutics
Diabetes Mellitus, Diabetic Peripheral Neuropathy
Immunonutrition for Diabetic Foot Ulcers
Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers (DFUs), which can have a devastating effect on patients' lives and can lead to life threatening infection, amputations, and even death.
- Conditions
- Diabetes Mellitus, Diabetic Peripheral Neuropathy, Diabetic Foot Ulcer
- Trial name
- NCT05281562
- Testing
- Lovaza, L-Arginine Powder, Vitamin C
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Prisma Health-Midlands
Diabetic Foot Ulcer
Study of Oasis Ultra in Diabetic Foot Ulcers
Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.
- Trial name
- NCT01835379
- Testing
- Oasis, Standard
- Where
- 16 sites in United States
- Volunteers
- 82 people
- Sponsor
- Healthpoint
Diabetic Foot
Removable Walker for Neuropathic Ulcers
1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer 2.
- Trial name
- NCT01005264
- Testing
- non-removable fiberglass, Stabil-D®
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- IRCCS Multimedica
Chronic Skin Ulcer, Diabetic Foot Ulcer
Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers
This randomized controlled trial will compare platelet rich plasma dressing with normal saline dressing for the treatment of chronic non healing cutaneous ulcers, including diabetic foot ulcers, venous leg ulcers, pressure…
- Trial name
- NCT07420868
- Testing
- Platelet Rich Plasma Dressing, Normal Saline Dressing
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Multan Medical And Dental College
Diabetes Mellitus, Ulcer Foot
Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern…
- Conditions
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer
- Trial name
- NCT05251480
- Testing
- Standard of Care, DermGEN™
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- DeCell Technologies Inc.
Obliterans, Arteriosclerosis, Peripheral Arterial Disease
Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: A Comparative Study
Endovascular interventions, such as balloon angioplasty and stenting, are commonly used for PAD due to their proven safety and effectiveness. However, traditional treatments for chronic non-healing wounds are often insufficient.
- Conditions
- Obliterans, Arteriosclerosis, Peripheral Arterial Disease, Diabetic Foot
- Trial name
- NCT06724276
- Testing
- balloon angioplasty and stenting of lower extremity vessels + fibroblasts, balloon angioplasty and stenting of lower extremity vessels
- Where
- Kazakhstan
- Volunteers
- 116 people
- Sponsor
- Tulip Medicine
Diabetic Foot Ulcers, Diabetic Wound
The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer
The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of…
- Trial name
- NCT05850611
- Testing
- Methylene Blue, Milk (control), Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
- Where
- Iran
- Volunteers
- 20 people
- Sponsor
- Mashhad University of Medical Sciences