Clinical trials: Diabetic Foot Ulcers
Diabetic Foot, Chronic Foot Ulcer
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.
- Conditions
- Diabetic Foot, Chronic Foot Ulcer, Wound Healing, Foot Ulcer
- Trial name
- DFUs (NCT05506215)
- Testing
- SynPath Acellular Dermal Matrix plus Off-loading Device, Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- PolyNovo Biomaterials Pty Ltd.
Diabetic Foot Ulcers (DFUs)
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3.
- Trial name
- NCT07565506
- Testing
- Antimicrobial agent
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Lakewood-Amedex Inc
Diabetic Foot Ulcer
High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers
Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was…
- Trial name
- NCT04300205
- Testing
- High intensity LED light device
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- Illumacell Inc.
Wound Heal, Ulcer
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Trial name
- IDEAL (NCT06616844)
- Testing
- InnovaMatrix® AC
- Where
- 21 sites in United States
- Volunteers
- 235 people
- Sponsor
- ConvaTec Inc.
Chronic Wound, Venous Leg Ulcer
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03662997
- Testing
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing, Hydrocellular Multi-Layer Foam Dressing
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Molnlycke Health Care AB
Lower Extremity Chronic Ulcers in Diabetics
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
- Trial name
- NCT01421966
- Testing
- CureXcell®
- Where
- 37 sites in United States, Canada and 1 more
- Volunteers
- 285 people
- Sponsor
- Macrocure Ltd.
Diabetic Foot Ulcer
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
The purpose of this study was to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers.
- Trial name
- NCT01645891
- Testing
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Where
- 33 sites in United States
- Volunteers
- 146 people
- Sponsor
- Electrochemical Oxygen Concepts, Inc.
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
- Trial name
- NCT03183726
- Testing
- ALLO-ASC-DFU
- Volunteers
- 4 people
- Sponsor
- Anterogen Co., Ltd.
Diabetes, Diabetic Foot Ulcer
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU).
- Conditions
- Diabetes, Diabetic Foot Ulcer, Non-healing Wound
- Trial name
- NCT02657876
- Testing
- ExpressGraft-C9T1 Skin Tissue
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Diabetic Foot Ulcer
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally…
- Trial name
- NCT00764361
- Testing
- doxycycline
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NanoSHIFT LLC
Chronic Wounds, Burns
THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions…
- Conditions
- Chronic Wounds, Burns, Pressure Ulcer, Traumatic Wounds
- Trial name
- NCT07617961
- Testing
- THERAVEX TISSUE CARE SPRAY PLUS
- Where
- Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Biointelligent Technology Systems SL
Diabetic Foot Infection
PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers
The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus / VULNOLIGHT® to the Usual Care, versus the treatment…
- Trial name
- PHOTOFINISH (NCT05613985)
- Testing
- Usual Care alone, System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
- Where
- 7 sites in Italy
- Volunteers
- 78 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Chronic Diabetic Foot Ulcers
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.
- Trial name
- NCT00632008
- Testing
- Soluble beta-glucan (SBG)
- Where
- 11 sites in United Kingdom
- Volunteers
- 122 people
- Sponsor
- Biotec Pharmacon ASA
Diabetic Foot Ulcer (DFU), Lower Extremity
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care.
- Trial name
- NCT07116876
- Testing
- Graft Application, Wound Dressing Material
- Where
- 17 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeNet Health
Diabetic Foot Ulcers
dHACM In the Treatment of Diabetic Foot Ulcers
A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix plus standard of care. Safety and effectiveness will be monitored throughout the study.
- Trial name
- NCT02587104
- Testing
- EpiFix
- Where
- Canada
- Volunteers
- 16 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer, Diabetic Foot
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
- Trial name
- NCT04564443
- Testing
- Medaxis Debritom+, Sharp Surgical Debridement, Additional Outer Dressing Application
- Where
- 6 sites in United States
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Medaxis, LLC
Diabetic Foot Ulcer, DFU
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks…
- Conditions
- Diabetic Foot Ulcer, DFU, Diabetic Foot Ulcer (DFU), Foot Ulcer Due to Type 1 Diabetes Mellitus
- Trial name
- RENEW (NCT07086443)
- Testing
- Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Sequence LifeScience, Inc.
Diabetic Foot Ulcer
Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers
Remedor has developed a patented technology (RMD-G1), which comprises erythropoietin (EPO) as the active pharmaceutical ingredient (API) in a carbopol-based hydrogel with an FN matrix.
- Trial name
- Remede d'Or (NCT02361931)
- Testing
- A hydrogel containing erythropoietin, Hydrogel (as a part of SOC)
- Where
- 5 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Remedor Biomed Ltd
Diabetic Foot Ulcer
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes.
- Trial name
- NCT00820703
- Testing
- Nexagon®, Nexagon® vehicle
- Where
- New Zealand
- Volunteers
- 24 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Diabetic Foot
BE Study of Metformin GSK 500mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study.
- Trial name
- BA/BE 173/11 (NCT01710527)
- Testing
- Metformin 500mg, Glucophage 500mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline