Clinical trials: Leg Ulcer
Venous Hypertension Ulcers, Venous Stasis Ulcer
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers.
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Trial name
- MUSTCOOL (NCT02626156)
- Testing
- Cooling gel pack, Cooling cotton pack
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medical University of South Carolina
Diabetic Foot Ulcer (DFU)
Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin…
- Trial name
- NCT07046403
- Testing
- High Purity Type-I Collagen-based Skin Substitute and SOC, Dehydrated Human Amnion / Chorion Membrane and SOC
- Where
- 4 sites in India
- Volunteers
- 120 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Foot Ulcer
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients.
- Trial name
- NCT06065488
- Testing
- ankle kinesio tap
- Where
- Egypt
- Volunteers
- 74 people
- Sponsor
- MTI University
Varicose Ulcer
Negative Pressure Vs. Compression in Venous Ulcers
This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.
- Trial name
- NCT03688841
- Testing
- Bridged V.A.C.® with compression therapy, Conventional Compression Therapy
- Where
- Ireland
- Volunteers
- 50 people
- Sponsor
- Western Vascular Institute, Ireland
Diabetic Foot
Physical Activity Assessment of Patients With Diabetic Foot Wounds
The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition.
- Trial name
- EFADDIAP (NCT04582357)
- Testing
- Physical activity program
- Sponsor
- University Hospital, Lille
Diabetic Foot, Peripheral Arterial Disease
Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD).
- Trial name
- NCT02460081
- Testing
- PDA-002
- Where
- United States
- Sponsor
- Celularity Incorporated
Diabetic Foot, Critical Limb Ischemia
Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Mesenchymal Stem Cells, Umbilical Cord
- Trial name
- NCT01216865
- Testing
- umbilical cord mesenchymal stem cells, Standard Therapy
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Qingdao 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
Efficacy and Safety of URGOBD001 Compression System
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous…
- Trial name
- FUTURE (NCT05158764)
- Testing
- Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification
- Where
- France
- Volunteers
- 178 people
- Sponsor
- Laboratoires URGO
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
Venous Leg Ulcers
Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with venous leg ulcers.
- Trial name
- NCT02222467
- Testing
- KLOX BioPhotonic System
- Where
- 4 sites in Canada
- Volunteers
- 10 people
- Sponsor
- KLOX Technologies Inc.
Diabetic Foot
Negative Pressure Wound Therapy in Diabetic Wounds
Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius.
- Trial name
- NCT05041244
- Testing
- Negative pressure wound therapy delivered through VAC, Standard of care
- Where
- Mauritius
- Volunteers
- 80 people
- Sponsor
- University of Mauritius
Ulcer Venous, Wound Heal
Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU
The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs .
- Trial name
- NCT06400875
- Testing
- InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer
Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene, diet and life style.
- Trial name
- NCT02632877
- Testing
- Pirfenidone with MODD, Ketanserin
- Where
- 2 sites in Mexico
- Volunteers
- 60 people
- Sponsor
- University of Guadalajara
Diabetic Foot, Stem Cell
Stem Cell Derived Exome for Treatment of Diabetic Foot
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
- Trial name
- NCT06480123
- Testing
- Skin drug prepared with exome originated from stem cell
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months
- Trial name
- NCT04590703
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- 8 sites in South Korea
- Volunteers
- 73 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
Intensive Glycemic Control For Diabetic Foot Ulcer Healing
With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic foot ulcer healing rates.
- Trial name
- INGLOBE (NCT04323462)
- Testing
- Insulin Glargine, Diabetic DM
- Where
- 2 sites in India
- Volunteers
- 326 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Diabetic Foot Ulcers
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
- Trial name
- NCT02209051
- Testing
- AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Venous Leg Ulcer
Assessment of the Evolution of Wound Biomarkers in Venous Leg Ulcers Treated With KLOX Biophotonic System
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU).
- Trial name
- NCT03593369
- Testing
- KLOX BioPhotonic System (single treatment)+SOC, KLOX BioPhotonic System (consecutive treatments)+SOC, Standard of Care (SOC)
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- KLOX Technologies Inc.
Venous Leg Ulcer
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
- Trial name
- HEAL I (NCT03544788)
- Testing
- Cirvo™ Therapy
- Where
- United States
- Sponsor
- Radial Medical, Inc.