Clinical trials: Ulcer, Leg
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Diabetic Foot Ulcer
MIRODERM H2H DFU Study
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
- Trial name
- H2H-DFU (NCT03232333)
- Testing
- Biologic wound graft
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Miromatrix Medical Inc.
Venous Ulcer, Venous Stasis Ulcer
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Conditions
- Venous Ulcer, Venous Stasis Ulcer, Ulcer
- Trial name
- NCT01853384
- Testing
- HP802-247, HP802-247 Vehicle
- Where
- 46 sites in Belgium, Czechia and 3 more
- Volunteers
- 252 people
- Sponsor
- Healthpoint
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
Varicose Veins, Venous Stasis
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins…
- Conditions
- Varicose Veins, Venous Stasis, Venous Insufficiency
- Trial name
- DESIVI (NCT03850496)
- Testing
- Revitive IX Neuromuscular Stimulation Device
- Volunteers
- 76 people
- Sponsor
- Imperial College London
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Lower Extremity or Diabetic Foot Ulcers, Bacterial Infection
Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement…
- Trial name
- NCT02294175
- Testing
- Larval Debridement Therapy, Bedside Sharp Debridement
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- North Florida Foundation for Research and Education
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-South (NCT01217463)
- Testing
- Trafermin 0.01% spray
- Where
- 24 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Olympus Biotech Corporation
Diabetic Foot Ulcer
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers…
- Trial name
- NCT00659646
- Testing
- gentamicin-collagen sponge and levofloxacin, Levofloxacin only
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Innocoll
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
Diabetic Foot Ulcer, Offloading
Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected.
- Trial name
- NCT02783066
- Testing
- Offloading boot: PulseFlow
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Baylor College of Medicine
Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US.
- Trial name
- NCT03476876
- Testing
- Dermacell, Integra
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Baylor College of Medicine
Venous Leg Ulcers, Mixed Leg Ulcers
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs.
- Trial name
- NCT01036438
- Testing
- Mepilex Ag, Mepilex without Ag
- Where
- 44 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Molnlycke Health Care AB
Neuropathic Diabetic Ulcer - Foot
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
- Trial name
- NCT01396837
- Testing
- RedDress Wound Care System (RD1)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- RedDress Ltd.
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
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-2 (NCT02447172)
- Testing
- Gentamicin Collagen sponge
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 524 people
- Sponsor
- Innocoll
Diabetic Neuropathies
Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
- Trial name
- FOCA-II (NCT04008745)
- Testing
- Educational and home-based physical therapy by foot-related exercises
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- University of Sao Paulo General Hospital
Diabetic Foot Ulcers
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers.
- Trial name
- NCT01454401
- Testing
- LeucoPatch treatment
- Where
- 7 sites in Denmark, Sweden
- Volunteers
- 60 people
- Sponsor
- Reapplix