Clinical trials: Diabetic Foot
Diabetic Foot Ulcer
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human…
- Trial name
- NCT04918784
- Testing
- Restrata®, Wound Dressing
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Acera Surgical, Inc.
Diabetic Neuropathies
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
- Trial name
- NCT02790931
- Testing
- Intervention Group
- Where
- Brazil
- Volunteers
- 78 people
- Sponsor
- University of Sao Paulo General Hospital
Diabetic Foot Infections
Diabetic Foot Infection Antibiotic Study
This is a pilot study to explore the effects of long-course versus short course antibiotics on wound healing in surgically managed diabetic foot infections.
- Trial name
- NCT01539811
- Testing
- Surgical incision and drainage of diabetic foot infection, Short course antibiotics, Long course antibiotics
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Prisma Health-Upstate
Diabetic Foot Infections
Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus
Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to…
- Trial name
- NCT02737722
- Testing
- Bisphosphocin Nu-3
- Where
- 3 sites in United States
- Volunteers
- 31 people
- Sponsor
- Lakewood-Amedex Inc
Diabetic Foot Ulcer, Diabetic Foot
Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer
In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes.
- Trial name
- NCT01844479
- Testing
- diabetic foot orthotic, Standard innersole
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Michigan
Diabetic Foot Ulcer
PriMatrix for the Management of Diabetic Foot Ulcers
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment.
- Trial name
- NCT03010319
- Testing
- PriMatrix Dermal Repair Scaffold, Secondary Dressings, Offloading device
- Where
- 17 sites in United States
- Volunteers
- 226 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
Preventing Diabetic Foot Ulcers Through Cleaner Feet
Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes.
- Trial name
- NCT03503370
- Testing
- Chlorhexidine
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- VA Office of Research and Development
Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy.
- Trial name
- NCT04055090
- Testing
- Long-Term Follow-Up of Patients who Received Engensis (VM202)
- Where
- 14 sites in United States
- Volunteers
- 101 people
- Sponsor
- Helixmith Co., Ltd.
Painful Diabetic Neuropathy, Diabetic Neuropathy
The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy
The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores…
- Conditions
- Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathy
- Trial name
- NCT02643251
- Testing
- Clonidine Hydrochloride Topical Gel, 0.1%, Clonidine Hydrochloride Gel Comparator
- Where
- 25 sites in United States
- Volunteers
- 138 people
- Sponsor
- BioDelivery Sciences International
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Pressure Ulcer, Leg Ulcer
Evaluation Of An Advanced Borderless Dressing
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03146845
- Testing
- ALLEVYN Life Non-Bordered, Standard Care
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot, Diabetic Foot Ulcer
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg
- Trial name
- NCT05579743
- Testing
- Remote wound monitoring technology
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Johns Hopkins University
Foot Ulcer, Diabetic
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
- Trial name
- NCT01858545
- Testing
- MatriStem, Cellular Dermal Replacement Tissue
- Where
- 9 sites in United States
- Volunteers
- 56 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.
- Trial name
- NCT00958711
- Testing
- Unite Biomatrix, Saline and Gauze
- Where
- 11 sites in United States
- Volunteers
- 90 people
- Sponsor
- Baxter Healthcare Corporation
Surgical Wound, Diabetes
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
- Conditions
- Surgical Wound, Diabetes, Amputation Wound, Incision Wound
- Trial name
- NCT03960463
- Testing
- Transcu O2®
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Baylor College of Medicine
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Painful Diabetic Neuropathy, Diabetic Neuropathy
Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathy
- Trial name
- NCT02068027
- Testing
- Clonidine Gel 0.1%
- Where
- 23 sites in United States
- Volunteers
- 260 people
- Sponsor
- BioDelivery Sciences International
Diabetic Foot Ulcer, Amputation
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the…
- Trial name
- NCT00393510
- Testing
- TCM
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- Chinese University of Hong Kong
Diabetic Foot Infection
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of…
- Trial name
- OneStep-2 (NCT01594762)
- Testing
- Topical pexiganan cream 0.8%, Standard wound care
- Where
- 39 sites in United States
- Volunteers
- 200 people
- Sponsor
- Dipexium Pharmaceuticals, Inc.
Wound Heal, Peripheral Artery Disease
Safety and Efficacy of the Noxsano Wound Care Bandage
This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity…
- Conditions
- Wound Heal, Peripheral Artery Disease, Ulcer, Leg, Ulcer Foot
- Trial name
- NCT04123093
- Testing
- Noxsano Bandage (Healthy Volunteers), Noxsano Bandage (Wound Care)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- OhioHealth