Clinical trials: Leg Ulcer
Diabetic Foot Ulcer
FeetSee Thermal Images Collection Protocol in Diabetes Patients
Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes.
- Trial name
- NCT07300163
- Testing
- FeetSee thermal camera
- Where
- 4 sites in Lithuania, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Diabetis JSC
Diabetic Foot Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Foot Ulcer, Diabetic
Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients
Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.
- Trial name
- ORTHODIAB (NCT01956162)
- Testing
- Orthèse Diabète, "Conventional" Device
- Where
- France
- Volunteers
- 118 people
- Sponsor
- Proteor Group
Venous Leg Ulcer, Venous Insufficiency of Leg
Preliminary Investigation of a Smart Compression Therapy Prototype
Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits.
- Trial name
- PRESUF-VLU (NCT05610241)
- Testing
- Compression Therapy System Prototype, Standard Compression
- Where
- Ireland
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Diabetic Foot
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective…
- Trial name
- NCT01898923
- Testing
- ON101 Cream, Aquacel® Hydrofiber® dressing
- Where
- 21 sites in United States, China and 1 more
- Volunteers
- 236 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
- Trial name
- NCT03624023
- Testing
- TWB-103
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- Transwell Biotech Co., Ltd.
Non-healing Wounds
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
- Trial name
- NCT04746573
- Testing
- Natrox Topical Oxygen Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inotec AMD Limited
Diabetic Foot Ulcer, Diabetic Foot
Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer, Ulcer Foot
- Trial name
- NCT06564831
- Testing
- SLAM + SOC, SOC
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Applied Biologics, LLC
Wound Healing
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
- Trial name
- NCT01022216
- Testing
- Procellera™ Wound Dressing with V.A.C.® Therapy, V.A.C.® Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vomaris Innovations
Diabetic Foot
Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration
The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.
- Trial name
- MASTER (NCT06053047)
- Testing
- Bluedrop Monitoring Service (BMS)
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Bluedrop Medical Limited
Leg Ulcers
Biatain Ag vs Biatain in the Treament of Leg Ulcers
the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers…
- Trial name
- NCT00807664
- Testing
- Biatain Ag, Biatain
- Volunteers
- 182 people
- Sponsor
- Coloplast A/S
Foot Ulcer, Diabetic
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
The primary objective is to: Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
- Trial name
- NCT01013792
- Testing
- Wound Dressing
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Solventum US LLC
Venous Leg Ulcers
Effectiveness of Aurix Therapy in Venous Leg Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving…
- Trial name
- NCT02940587
- Testing
- Aurix
- Where
- United States
- Sponsor
- Cytomedix
Diabetic Foot Ulcer
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
- Trial name
- NCT05046158
- Testing
- Transforming Powder Dressing, Standard of care topical wound agents and dressings
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- ULURU Inc.
Varicose Ulcer
Cost Evaluation of Venous Leg Ulcers Management
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
- Trial name
- EPIC (NCT02728986)
- Testing
- Profore, Coban2
- Where
- France
- Volunteers
- 176 people
- Sponsor
- Solventum US LLC
Diabetic Foot, Varicose Ulcer
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.
- Conditions
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- Trial name
- NCT00521027
- Testing
- Versajet Hydrosurgery System, Conventional surgical debridement techniques
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R).
- Trial name
- NCT01181453
- Testing
- Dermagraft, Comparator
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.
- Trial name
- NCT06938685
- Testing
- Standard of Care, NeoThelium FT
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
Diabetic Foot Ulcer (DFU), Amnio-Maxx
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Trial name
- NCT07209475
- Testing
- Amnio-Maxx® Dual Layer Amnion Patch, Standard of Care (Investigator Choice)
- Where
- 8 sites in United States
- Volunteers
- 248 people
- Sponsor
- Royal Biologics