Clinical trials: Diabetic Feet
Diabetic Foot Ulcer, Diabetic Foot
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer, Diabetic
- Trial name
- CAMPAIGN (NCT06600724)
- Testing
- Standard of Care, EPIEFFECT, EPIXPRESS
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
- Trial name
- NCT00387101
- Testing
- Dermal - Living Skin Replacement (Dermal - LSR)
- Where
- 12 sites in United States
- Volunteers
- 288 people
- Sponsor
- ApoPharma
Diabetic Foot Ulcers
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a…
- Trial name
- STRIDE 2 (NCT01849965)
- Testing
- DSC127, Standard of Care gel, Aquasite
- Where
- 56 sites in United States, Canada and 2 more
- Volunteers
- 396 people
- Sponsor
- Integra LifeSciences Corporation
Chronic Diabetic Foot Ulcer
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks.
- Trial name
- NCT00709514
- Testing
- DCB-WH1 ointment
- Where
- Taiwan
- Volunteers
- 41 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer, Pressure Injury
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound
- Trial name
- NCT04593693
- Testing
- Invia Motion Endure NPWT system
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medela AG
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of…
- Conditions
- Diabetic Foot Infection, Non-healing Wound, Non-healing Diabetic Foot Ulcer
- Trial name
- NCT04450693
- Testing
- TTAX01, Standard care
- Where
- 16 sites in United States
- Volunteers
- 106 people
- Sponsor
- BioTissue Holdings, Inc
Diabetic Foot Ulcer, Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment.
- Trial name
- NCT03717233
- Testing
- Exoskeleton
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Results Group LLC
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North 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-North (NCT01217476)
- Testing
- Trafermin 0.01% spray
- Where
- 37 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 207 people
- Sponsor
- Olympus Biotech Corporation
Diabetic Foot Ulcers
Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K
The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft. The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to…
- Trial name
- NCT02707406
- Testing
- NEOX®CORD 1K, standard of care
- Where
- 22 sites in United States, Canada
- Volunteers
- 124 people
- Sponsor
- BioTissue Holdings, Inc
Diabetes Mellitus Foot Ulcer
Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.
Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions.
- Trial name
- NCT05604352
- Testing
- DiaSole
- Volunteers
- 30 people
- Sponsor
- Kaydiar Ltd
Diabetic Foot Disease, Diabetic Foot Infection
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk…
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections, Diabete Type 1
- Trial name
- DIAFOOTEM (NCT07910721)
- Testing
- Solsius SelfCare
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Solsius
Venous Leg Ulcer, Diabetic Foot Ulcer
The Omeza Protocol for Chronic Ulcers
This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.
- Trial name
- NCT04198441
- Testing
- Wound dressing
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Omeza, LLC
Foot Ulcer
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers.
- Trial name
- NCT00069446
- Testing
- rhuMAb VEGF (telbermin)
- Volunteers
- 50 people
- Sponsor
- Genentech, Inc.
Diabetic Foot Ulcer
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.
- Trial name
- NCT01427569
- Testing
- IZN-6D4 Gel
- Where
- Israel
- Volunteers
- 82 people
- Sponsor
- Izun Pharma Ltd
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® Esterase for Screening Wound Infection at Point of Care
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT04614870
- Testing
- DETEC® Esterase
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Progenitec Inc.
Diabetic Foot, Peripheral Arterial Disease
Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD).
- Trial name
- NCT02460081
- Testing
- PDA-002
- Where
- United States
- Sponsor
- Celularity Incorporated
Diabetic Foot
Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot.
- Trial name
- NCT00224796
- Testing
- V.A.C. ® System
- Volunteers
- 146 people
- Sponsor
- KCI USA, 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
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Diabetic Foot Ulcer, Venous Leg Ulcer
Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound Infection
- Trial name
- NCT05772507
- Testing
- URGO AWC_008 dressing or URGO AWC_022 dressing
- Where
- France
- Volunteers
- 85 people
- Sponsor
- Laboratoires URGO