Clinical trials: Foot Ulcers, Diabetic
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer
Blue Light Photobiomodulation Therapy on Neuroischemic Patients
This is a pilot case/control clinical study on a group of outpatients with diabetic foot lesions aiming to verify the efficacy and safety of the Blue light photobiomodulation therapy with EmoLED medical device, in addition to…
- Trial name
- HERMES (NCT04831606)
- Testing
- debridement, Offloading, Advanced dressing
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Emoled
Diabetic Foot Ulcer
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
- Trial name
- OG/SNaP (NCT01623882)
- Sponsor
- KCI USA, 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, Venous Leg Ulcer
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound Dehiscence, Traumatic Wounds
- Trial name
- EVIDENT (NCT04920253)
- Testing
- Study Device Debridement, SOC Debridement
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Medaxis, LLC
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
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
Diabetes, Diabetic Foot
Wound Assessment Using Spectral Imaging EU/UK
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
- WAUSI EU/UK (NCT05581966)
- Testing
- DV-SSP Imaging
- Where
- Ireland
- Volunteers
- 72 people
- Sponsor
- SpectralMD
Diabetic Foot Ulcers
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT00432965
- Testing
- Moist Wound Therapy, VAC Therapy
- Where
- 25 sites in United States, Canada
- Volunteers
- 335 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcers
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
- Trial name
- NCT00605189
- Testing
- Powered Suction Pump (VAC Freedom), Powered Suction Pump, MWT
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcer
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels.
- Trial name
- RENEW (NCT05607979)
- Testing
- Lavior Diabetic Wound Gel, Smith & Nephew Solosite Gel Hydrogel Wound Dressing
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Lavior Pharma Inc.
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
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, 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
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85…
- Trial name
- NCT06584617
- Testing
- Berovenal®, NU-GEL Hydrogel with Alginate
- Where
- 9 sites in Germany, Poland
- Volunteers
- 66 people
- Sponsor
- VULM s.r.o.
Diabetes Mellitus, Ulcer Foot
Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern…
- Conditions
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer
- Trial name
- NCT05251480
- Testing
- Standard of Care, DermGEN™
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- DeCell Technologies Inc.
Diabetic Foot Ulcers
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
- Trial name
- NCT05417425
- Testing
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Omeza, LLC
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
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
- NCT04176120
- Testing
- TTAX01, Standard Care
- Where
- 16 sites in United States
- Volunteers
- 220 people
- Sponsor
- BioTissue Holdings, Inc
Diabetic Foot Ulcer
A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix
This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.
- Trial name
- NCT06444906
- Testing
- Dermacyte Matrix, Standard of Care (SOC)
- Volunteers
- 85 people
- Sponsor
- Merakris Therapeutics