Clinical trials: Foot Ulcer, Diabetic
Diabetic Foot Ulcer, Lower Extremity Wound
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
- Trial name
- NCT03044132
- Testing
- DermACELL AWM
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- LifeNet Health
Diabetic Foot Ulcer, Dehiscence of Amputation Stump
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint.
- Conditions
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- Trial name
- Odinn (NCT04257370)
- Testing
- Kerecis™ Omega3 Wound, Standard of care
- Where
- France
- Volunteers
- 260 people
- Sponsor
- Kerecis Ltd.
Diabetic Foot Ulcer
A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers
This prospective case series is to gain additional clinical experience in the treatment of diabetic foot ulcers, by documenting and relating patient history (including baseline wound characteristics) and clinical outcomes…
- Trial name
- NCT02799121
- Testing
- ReGenerCell™ Autologous Cell Harvesting Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Avita Medical
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
Efficacy of Human Placental Graft in Diabetic Foot Ulcers
To determine the efficacy of full-thickness placental allograft in chronic wound healing
- Trial name
- NCT03708029
- Testing
- Revita Allograft
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- StimLabs
Diabetic Foot Ulcer, Diabetes Mellitus
CSTC1 for Diabetic Foot Ulcers Phase II Study
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Trial name
- NCT01813305
- Testing
- CSTC1, CSTC1 Matched vehicle
- Where
- Taiwan
- Volunteers
- 124 people
- Sponsor
- Charsire Biotechnology Corp.
Leg Ulcer
Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers
This is a single centre open label study measuring microcirculatory flux using Speckle imaging Device. Microcirculation will be measured using laser speckle contrast imaging, at baseline and with the device active for 30 minutes…
- Trial name
- NCT03186560
- Testing
- gekoTM
- Where
- 3 sites in United Kingdom
- Volunteers
- 34 people
- Sponsor
- Firstkind Ltd
Diabetic Foot Ulcers
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers.
- Trial name
- DFU (NCT01596920)
- Testing
- Tissue, Control
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Osiris Therapeutics
Foot Ulcer, Diabetic
A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers
This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers.
- Trial name
- NCT00351767
- Testing
- telbermin
- Volunteers
- 170 people
- Sponsor
- Genentech, Inc.
Diabetic Foot Ulcer
Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer
The purpose of this study is to determine the safety and efficacy of the topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a…
- Trial name
- NCT00658957
- Testing
- gentamicin-collagen sponge
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Innocoll
Wounds and Injuries, Diabetes
Gene Therapy to Improve Wound Healing in Patients With Diabetes
Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds.
- Conditions
- Wounds and Injuries, Diabetes, Diabetic Foot Ulcers, Foot Wounds
- Trial name
- NCT00065663
- Testing
- GAM501
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Tissue Repair Company
Diabetic Foot Ulcer
A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the…
- Trial name
- NCT02236793
- Testing
- BioChaperone PDGF-BB, Standard of Care
- Where
- 32 sites in India
- Volunteers
- 252 people
- Sponsor
- Adocia
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
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
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.
- Trial name
- NCT06557122
- Testing
- SOC and Advanced Bioengineered Skin Substitute, SOC and Active Comparator
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Encoll Corp
Wound Infection, Wound Heal
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a…
- Trial name
- INDICATE (NCT04979637)
- Sponsor
- ConvaTec Inc.
Diabetic Foot, Diabetic Foot Ulcer
DERMALIX Efficacy on Diabetic Foot Ulcers
(DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was developed by Ege University School of Pharmacy Department of Pharmaceutical Technology.
- Trial name
- DERMAN (NCT03136822)
- Testing
- Standard Dressing, DERMALIX
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Dermis Pharma
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
Diabetic Foot Ulcers
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
- Trial name
- NCT01070433
- Testing
- MEBO Wound Ointment (MEBO), Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Skingenix, Inc.