Clinical trials: Non-Healing Ulcers
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
Non-healing Wounds
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
- Trial name
- NCT04746573
- Testing
- Natrox Topical Oxygen Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inotec AMD Limited
Diabetic Foot Ulcer
Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers
The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).
- Trial name
- NCT02870816
- Testing
- Tissue Engineered Skin Substitute, Offloading, Amnionic Membrane Graft
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Professional Education and Research Institute
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
Venous Leg Ulcers
Effectiveness of Aurix Therapy in Venous Leg Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving…
- Trial name
- NCT02940587
- Testing
- Aurix
- Where
- United States
- Sponsor
- Cytomedix
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
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.
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
Diabetic Foot Ulcer
Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)
This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.
- Trial name
- NCT06111183
- Testing
- AUP1602-C
- Where
- 10 sites in Germany, Italy and 1 more
- Volunteers
- 64 people
- Sponsor
- Aurealis Oy
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 Ulcers
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched…
- Trial name
- NCT01816633
- Testing
- AutoloGel
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Cytomedix
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 Foot Ulcer (DFU), Chronic Foot Ulcers
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in…
- Trial name
- NCT06681428
- Testing
- Allograft
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tides Medical
Venous Leg Ulcer, Autologous Adipose Stromal Vascular Fraction
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.
- Conditions
- Venous Leg Ulcer, Autologous Adipose Stromal Vascular Fraction, Adipose-Derived Mesenchymal Stem Cells, Mesenchymal Stem Cells
- Trial name
- NCT05165459
- Testing
- Venous leg ulcer treatment with adipous SVF
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Szeged University
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.
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.
Peripheral Arterial Disease
Ultrasound Cavitation Therapy for CLI
In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral…
- Trial name
- NCT05749250
- Testing
- Acoustic cavitation of ultrasound enhancing agents
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Virginia
Neuropathic Diabetic Foot Ulcers
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care.
- Trial name
- NCT02833389
- Testing
- UTTR1147A
- Where
- 32 sites in United States, Denmark and 4 more
- Volunteers
- 72 people
- Sponsor
- Genentech, Inc.
Chronic Skin Ulcer, Diabetic Foot Ulcer
Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers
This randomized controlled trial will compare platelet rich plasma dressing with normal saline dressing for the treatment of chronic non healing cutaneous ulcers, including diabetic foot ulcers, venous leg ulcers, pressure…
- Trial name
- NCT07420868
- Testing
- Platelet Rich Plasma Dressing, Normal Saline Dressing
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Multan Medical And Dental College
Diabetic Foot Ulcer
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT01608776
- Testing
- MIST Therapy, SOC - Standard of Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Celleration, Inc.