Clinical trials: Chronic Leg Ulcer
Wound Healing, Diabetic Foot
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
- Conditions
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer, Foot Ulcer
- Trial name
- NCT06035523
- Testing
- Endoform™ Antibacterial, Endoform™ Natural, Symphony™
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Aroa Biosurgery Limited
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
Venous Leg Ulcer
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox…
- Trial name
- Granulox01 (NCT04181320)
- Testing
- Venous Leg Ulcer Standard of Care with Granulox
- Where
- 27 sites in Croatia, Czechia and 5 more
- Volunteers
- 128 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers
- Trial name
- NCT07039396
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC
Chronic Ulcers, Diabetic Foot Ulcers (DFU)
Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds
The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of…
- Conditions
- Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU, Ulcer
- Trial name
- NCT07414368
- Testing
- Corplex P is used to cover, protect, and provide a moist wound environment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- StimLabs
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Skin Ulcer Venous Stasis Chronic
Allogeneic ABCB5-positive Stem Cells for Treatment of CVU
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the medicinal product to be studied after two…
- Trial name
- NCT03257098
- Testing
- allo-APZ2-CVU
- Where
- 9 sites in Germany
- Volunteers
- 31 people
- Sponsor
- RHEACELL GmbH & Co. KG
Foot Ulcer, Diabetic
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety.
- Trial name
- NCT05586542
- Testing
- DERMASEAL, Plasma Film, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Vitruvian Medical Devices, Inc.
Diabetic Foot Ulcer
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
- Trial name
- FEENICS (NCT00662831)
- Testing
- Fragmin/ Dalteparin Sodium
- Where
- 63 sites in Austria, Belgium and 15 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
Ulcus Cruris
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients.
- Trial name
- NCT01434914
- Testing
- octenisept®
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Schülke & Mayr GmbH
Venous Leg Ulcer, Diabetic Foot Ulcer
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT03021811
- Testing
- KLOX LumiHeal BioPhotonic System
- Volunteers
- 100 people
- Sponsor
- KLOX Technologies Inc.
Ulcers, Wounds
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
- Trial name
- NCT00951080
- Testing
- Traditional NPWT System, SNaP Wound Care System
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- 3M
Leg Ulcers Venous, Leg Ulcer Arterial
Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems.
- Conditions
- Leg Ulcers Venous, Leg Ulcer Arterial, Leg Ulcer Mixed
- Trial name
- NCT03112395
- Testing
- Pio Medical Device
- Where
- 3 sites in Switzerland
- Volunteers
- 36 people
- Sponsor
- Piomic Medical AG
Diabetic Foot Ulcer
Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers
Remedor has developed a patented technology (RMD-G1), which comprises erythropoietin (EPO) as the active pharmaceutical ingredient (API) in a carbopol-based hydrogel with an FN matrix.
- Trial name
- Remede d'Or (NCT02361931)
- Testing
- A hydrogel containing erythropoietin, Hydrogel (as a part of SOC)
- Where
- 5 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Remedor Biomed Ltd
Lower Extremity Chronic Ulcers in Diabetics
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
- Trial name
- NCT01421966
- Testing
- CureXcell®
- Where
- 37 sites in United States, Canada and 1 more
- Volunteers
- 285 people
- Sponsor
- Macrocure Ltd.
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcer
Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers
This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the body including vasodilation and angiogenesis.
- Trial name
- ProNOx1 (NCT01982565)
- Testing
- NOx dressing, Standard of Care
- Where
- 10 sites in United Kingdom
- Volunteers
- 130 people
- Sponsor
- Edixomed Ltd
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S
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
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute