Clinical trials: Non-Healing Ulcer of Skin
Diabetic Foot Ulcer (DFU)
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT07290673
- Testing
- FoundationDRS Solo, Standard of Care
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Samaritan Biologics
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
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 Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Venous Leg Ulcer, Venous Ulcer
Tissue Repair Gel in Venous Leg Ulcers (US)
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs).
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis
- Trial name
- TRIVIA (NCT06707090)
- Testing
- TR987 0.1% gel + Standard of Care, Standard of care
- Where
- 33 sites in United States
- Volunteers
- 312 people
- Sponsor
- TR Therapeutics
Diabetic Foot
Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities
This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in subjects ≥ 18 years old…
- Trial name
- MATRIX (NCT00493051)
- Testing
- GAM501, Standard of care
- Where
- 29 sites in United States
- Volunteers
- 124 people
- Sponsor
- Tissue Repair Company
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
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Non-healing Wound
Treatment of Wounds Using Oasis® ECM
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
- Trial name
- NCT03632031
- Testing
- Oasis Extracellular Matrix, Standard Care (in control arm)
- Where
- 2 sites in United Kingdom
- Volunteers
- 41 people
- Sponsor
- Cook Biotech Incorporated
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.
Diabetic Foot Ulcers (DFUs)
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC.
- Trial name
- NCT06767501
- Testing
- E-GRAFT ™, FIBRACOL™
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Skye Biologics Holdings, LLC
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
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 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
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Venous Leg Ulcers
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).
- Trial name
- NCT02312518
- Testing
- PRP Concepts Fibrin Bio-Matrix, Usual and Customary Practice
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- PRP Concepts, LLC
Skin Ulcer Venous Stasis Chronic, Mixed Arteriovenous Leg Ulcer
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.
- Trial name
- NCT01913704
- Testing
- NatroxTM Device
- Where
- 2 sites in Czechia
- Sponsor
- Inotec AMD Limited
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard…
- Conditions
- Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT05243810
- Testing
- EPC Silver Wound Gel
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Exciton Technologies Inc.