Clinical trials: Foot Ulcer, Diabetic
Diabetic Foot Ulcer
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.
- Trial name
- NCT01657474
- Testing
- Weekly application of EpiFix plus standard of care, Biweekly application of EpiFix plus standard of care
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer
Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).
- Trial name
- ASCEND (NCT05095389)
- Testing
- ADRCs, standard care
- Volunteers
- 290 people
- Sponsor
- Paracrine, INC.
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
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 (DFU)
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations.
- Trial name
- NCT06782386
- Testing
- OneStep Foot Scanner
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Bluedrop Medical Limited
Diabetic Foot Ulcer
Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)…
- Trial name
- NCT05687656
- Testing
- InnovaMatrix AC porcine placental ECM therapy
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- ConvaTec Inc.
Diabetes Mellitus, Foot Ulcer
REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury…
- Conditions
- Diabetes Mellitus, Foot Ulcer, Neuroischemic Foot Ulcer
- Trial name
- REOXDFU (NCT05413746)
- Testing
- Reoxcare antioxidant dressing
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Histocell, S.L.
Diabetic Foot Ulcers
A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.
The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
- Trial name
- NCT04945161
- Testing
- ON101 Cream
- Where
- Taiwan
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oneness Biotech Co., Ltd.
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
Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers
Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.
- Trial name
- DISCOVERY (NCT03110796)
- Testing
- Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2, Dressing without LU3103209
- Where
- 6 sites in Czechia, France and 4 more
- Volunteers
- 210 people
- Sponsor
- Laboratoires URGO
Foot Ulcer, Diabetic
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.
- Trial name
- NCT02647346
- Testing
- Daily use of podimetrics smart-foot mat
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- Podimetrics, Inc.
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- HEAL-4 (NCT07223515)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Dynamic Medical Services dba Acesso Biologics
Diabetic Foot Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
- Trial name
- NCT01537016
- Testing
- PROMOGRAN, Tielle
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Diabetic Foot Ulcer
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
- Trial name
- NCT06319287
- Testing
- PEP (Purified Exosome Product) / TISSEEL
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Rion Inc.
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
Diabetic Foot Ulcer, Venous Leg Ulcer
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal…
- Trial name
- NCT06453187
- Testing
- Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers, AmnioExcel Plus for Venous Leg Ulcers
- Where
- 13 sites in United States
- Volunteers
- 350 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 Infection, Diabetic Foot
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot…
- Trial name
- NCT05174806
- Testing
- Topical Pravibismane, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Microbion Corporation
Diabetic Foot
Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective…
- Trial name
- NCT01898923
- Testing
- ON101 Cream, Aquacel® Hydrofiber® dressing
- Where
- 21 sites in United States, China and 1 more
- Volunteers
- 236 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers…
- Trial name
- NCT00659646
- Testing
- gentamicin-collagen sponge and levofloxacin, Levofloxacin only
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Innocoll