Clinical trials: Non-Healing Ulcer of Skin
Venous Leg Ulcer
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Trial name
- NCT02104180
- Testing
- Urgotul, TulleGras M.S.
- Where
- 27 sites in France
- Volunteers
- 62 people
- Sponsor
- Mylan Inc.
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Venous Leg Ulcer
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs.
- Trial name
- NCT04901013
- Testing
- Affinity
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Venous Stasis Ulcer, Venous Leg Ulcer
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional…
- Trial name
- NCT04647240
- Testing
- MTX-001 (human amniotic fluid)
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- Merakris Therapeutics
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
Skin Ulcer Venous Stasis Chronic
Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application…
- Trial name
- NCT02742844
- Testing
- APZ2 application
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- RHEACELL GmbH & Co. KG
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
Ulcer Healing, Diabetic Foot Ulcer
Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers
The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®.
- Trial name
- NCT05797285
- Testing
- human keratin graft
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- ProgenaCare Global, LLC
Non-healing Wound, Diabetic Foot
AMNIODERM+ Medical Device Clinical Study
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC.
- Trial name
- AMNIODERM+ (NCT06442865)
- Testing
- AMNIODERM+
- Where
- Slovakia
- Volunteers
- 20 people
- Sponsor
- BioHealing s.r.o.
Diabetic Foot Ulcer
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus…
- Trial name
- PREPARE (NCT06618612)
- Testing
- Standard of Care, PuraPly AM, PuraPly XT
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Organogenesis
Foot Ulcer Chronic, Skin Ulcer Venous Stasis Chronic
Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds
This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery.
- Conditions
- Foot Ulcer Chronic, Skin Ulcer Venous Stasis Chronic, Pressure Ulcer
- Trial name
- NCT02307448
- Testing
- Platelet Rich Plasma, Standard of Care
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- ACR Biologics, LLC
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic…
- Trial name
- NCT07172893
- Testing
- DermaBind TL
- Where
- 10 sites in United States
- Volunteers
- 150 people
- Sponsor
- HealthTech Wound Care
Venous Leg Ulcer
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
- Trial name
- NCT06489028
- Testing
- allo-APZ2-CVU
- Where
- 15 sites in United States, Austria and 10 more
- Volunteers
- 250 people
- Sponsor
- RHEACELL GmbH & Co. KG
Venous Leg Ulcer, Venous Ulcer
Tissue Repair Gel in Venous Leg Ulcers in AU/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 (NCT06707103)
- Testing
- TR987 0.1% gel + Standard of Care, Standard of care
- Where
- 12 sites in United States, Australia
- Volunteers
- 312 people
- Sponsor
- TR Therapeutics
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
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 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 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 Ulcers
Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers
The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in…
- Trial name
- STRIDE 1 (NCT01830348)
- Testing
- DSC127
- Where
- 25 sites in United States
- Volunteers
- 266 people
- Sponsor
- Integra LifeSciences Corporation
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