Clinical trials: Chronic Ulcers of the Lower Limb
Diabetes Type I, Diabetes Type II
Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment
The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study.
- Trial name
- NCT02184455
- Testing
- DermGEN
- Where
- 2 sites in Canada
- Volunteers
- 11 people
- Sponsor
- Dr. Paul F. Gratzer
Diabetic Foot Ulcers
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
- Trial name
- NCT05417425
- Testing
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Omeza, LLC
Diabetic Foot Ulcers
A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)
This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care.
- Trial name
- DUNE (NCT01490879)
- Testing
- Nexagon® Low Dose, Nexagon® Medium Dose, Nexagon® High Dose
- Where
- 25 sites in United States, Russia and 1 more
- Volunteers
- 168 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Diabetic Foot Ulcers, Venous Ulcers
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the…
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- CMS (NCT02071979)
- Testing
- Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections
- Where
- 6 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Arteriocyte, Inc.
Chronic Ulcer of Lower Extremity
Plasma On Chronic Wounds for Epidermal Regeneration
Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects.
- Trial name
- POWER (NCT05855499)
- Testing
- CPtcube, CPTpatch
- Where
- 8 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Coldplasmatech
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
Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers
Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds
Use of a motorized waterjet to debride wounds to improve healing outcomes.
- Conditions
- Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers, Pressure Injuries, Traumatic Wounds and Injuries
- Trial name
- NCT07653165
- Testing
- Motion NPWT
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- West Boca Center for Wound Healing
Venous Insufficiency (Chronic)(Peripheral), Venous Reflux
Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional…
- Conditions
- Venous Insufficiency (Chronic)(Peripheral), Venous Reflux, Venous Insufficiency of Leg, Venous Stasis
- Trial name
- ARESQOLSAVES (NCT04758728)
- Testing
- Great saphenous vein stripping and varicectomies, Epinephrine Topical, normal saline
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Junior Doctors Network-Hellas
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.
Chronic Ulcer at Lower Leg
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
- Trial name
- NCT03808181
- Testing
- ChloraSolv
- Where
- 9 sites in Sweden
- Volunteers
- 59 people
- Sponsor
- RLS Global
Venous Leg Ulcers
Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs).
- Trial name
- NCT07510412
- Testing
- NuShield®
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions 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 Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
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
Venous Leg Ulcer, Chronic Wounds
Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
- Trial name
- NCT07335861
- Testing
- Hyalomatrix, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 122 people
- Sponsor
- NuScience Medical Biologics, LLC
Chronic Venous Hypertension With Ulcer
Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment
This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)
- Trial name
- NCT03935386
- Testing
- Standard Multi-layered Compression dressing, Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Solsys Medical LLC
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® Esterase for Screening Wound Infection at Point of Care
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT04614870
- Testing
- DETEC® Esterase
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Progenitec Inc.
Partial Thickness Wound, Pressure Ulcer
The RESPOND Registry
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer
- Trial name
- RESPOND (NCT03286452)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- 15 sites in United States
- Volunteers
- 310 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU).
- Trial name
- NCT01113515
- Testing
- Esmolol hydrochloride
- Where
- 5 sites in United States, India and 1 more
- Volunteers
- 44 people
- Sponsor
- Novalead Pharma Private Limited