Clinical trials: Diabetic Feet
Diabetic Foot, Ulcer Foot
SDRM® vs. Collagen for Diabetic Foot Ulcers
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing.
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Trial name
- NCT05883098
- Testing
- Wound debridement, Wound closure matrix application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Polymedics Innovations Inc.
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Diabetic Foot Ulcers
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2…
- Trial name
- NCT02312596
- Testing
- PRP Concepts Fibrin Bio-Matrix, Usual and Customary Practice
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- PRP Concepts, LLC
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
Diabetes Mellitus, Foot Ulcer
Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes
The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.
- Conditions
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Diabetic Neuropathies
- Trial name
- NCT01235260
- Testing
- Becaplermin nonusers, Becaplermin users
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Diabetes, Diabetic Foot
Wound Assessment Using Spectral Imaging US
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- NCT05415683
- Testing
- DV-SSP Imaging
- Where
- 11 sites in United States
- Volunteers
- 400 people
- Sponsor
- SpectralMD
Diabetic Foot Ulcers
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the…
- Trial name
- NCT01143727
- Testing
- Santyl, Tegaderm Hydrogel
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Healthpoint
Peripheral Arterial Disease, Diabetic Foot
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with…
- Trial name
- DFU-002 (NCT02264288)
- Testing
- PDA-002
- Where
- 45 sites in United States
- Volunteers
- 159 people
- Sponsor
- Celularity Incorporated
Diabetic Foot Ulcer
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be…
- Trial name
- NCT02209662
- Testing
- APIC-PRP
- Volunteers
- 274 people
- Sponsor
- Cytonics Corporation
Diabetic Foot, Foot Ulcer
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
- Conditions
- Diabetic Foot, Foot Ulcer, Ulcer Foot, DFU
- Trial name
- NCT07159282
- Testing
- XWRAP
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Applied Biologics, LLC
Diabetic Foot Ulcers
TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
- Trial name
- MxT Ag 05 (NCT01964521)
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United Kingdom
- Volunteers
- 24 people
- Sponsor
- Molnlycke Health Care AB
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
A Controlled Prospective Treatment Study to Evaluate the Efficacy of Vendaje.
The Goal of this study is to evaluate the wound volume reduction rate and the time to closure when using Vendaje to manage diabetic wounds. The participants will be treated weekly for up to 12 weeks.
- Trial name
- NCT06150209
- Testing
- Vendaje
- Sponsor
- BioStem Technologies
Non-infected Diabetic Foot Ulcer, Diabetic Foot
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Conditions
- Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound, Diabetic Foot Ulcer
- Trial name
- NCT06565156
- Testing
- BR-AM, Standard Care
- Where
- 17 sites in United States
- Volunteers
- 72 people
- Sponsor
- BioStem Technologies
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Foot Ulcer, Diabetic
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without…
- Trial name
- NCT01270633
- Testing
- PriMatrix, Standard of Care
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Integra LifeSciences Corporation
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
Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs.
- Trial name
- DFUs (NCT03855514)
- Testing
- NuShield
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer
The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers.
- Trial name
- NCT06231771
- Testing
- Allogeneic mesenchymal stem cells (MSCs), Normal Saline
- Volunteers
- 22 people
- Sponsor
- Supergenics Life Science Sdn. Bhd.