Clinical trials: Chronic Ulcer of Lower Extremity
Diabetic Foot Ulcer
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).
- Trial name
- NCT04104451
- Testing
- Corlicyte
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Colorado, Denver
Critical Limb Ischemia, Arteriosclerosis Obliterans
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury.
- Conditions
- Critical Limb Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease, Thromboangiitis Obliterans
- Trial name
- NCT02864654
- Testing
- ADRC injection, ADRC isolation, Liposuction
- Where
- Russia
- Volunteers
- 9 people
- Sponsor
- Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Diabetic Foot Ulcer, Venous Leg Ulcer
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- CHITOCHRONIC (NCT05570877)
- Testing
- ChitoCare medical Wound Healing Gel
- Where
- 9 sites in Croatia, Slovenia
- Volunteers
- 92 people
- Sponsor
- Primex ehf
Varicose Ulcer, Venous Insufficiency of Leg
Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency
This is a multicentre, quasi-experimental study to evaluate the Conformitè Europëenne-marked Compreflex standard calf and foot (with basic liner) under routine conditions.
- Trial name
- NCT05364112
- Testing
- Compreflex
- Where
- Malaysia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kuala Lumpur General Hospital
Varicose Ulcer
Preliminary Testing of New Treatment for Chronic Leg Wounds
Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a reasonable period of time. Although researchers have made great progress in understanding how the body repairs wounds, attempts to…
- Trial name
- NCT00000431
- Testing
- PDGF-B/Ad5
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Pennsylvania
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 Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds
The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds.
- Trial name
- COMBAT-H (NCT07872930)
- Testing
- Irrigation Solution for wounds, Hydrogel for wound care
- Volunteers
- 96 people
- Sponsor
- University of Calgary
Chronic Wounds, Diabetes
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers. Procedure includes topical administration of FGF-1 or placebo and evaluation of safety, pharmacokinetics, and wound improvement.
- Conditions
- Chronic Wounds, Diabetes, Venous Stasis Ulcers
- Trial name
- NCT00425178
- Testing
- FGF-1
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Venturis Therapeutics, Inc.
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg.
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer, Infrapopliteal Arterial Occlusive Disease
- Trial name
- NCT07827521
- Testing
- Lower-Extremity Revascularization, Donaperminogene Seltoplasmid
- Where
- 6 sites in China
- Volunteers
- 180 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Diabetic Foot Ulcer, Chronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers.
- Trial name
- NCT07444593
- Testing
- Biodynamik XT3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Biodynamik, Inc
Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer
Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds
Bacterial load is frequently associated with impaired healing of chronic wounds. As well, sharp debridement is often associated with pain, causing patient distress, and thereby occasionally contributing to inadequacy of…
- Conditions
- Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03182582
- Testing
- Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement, Scalpel/Curette Debridement
- Volunteers
- 22 people
- Sponsor
- Stanford University
Varicose Ulcer
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months.
- Trial name
- NCT00656383
- Testing
- Clients randomized to nurse-led clinic, Clients receive leg ulcer care in their homes
- Where
- 2 sites in Canada
- Volunteers
- 401 people
- Sponsor
- Queen's University
Foot Ulcer, Diabetic
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without…
- Trial name
- HEALED (NCT01729286)
- Testing
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- Integra LifeSciences Corporation
Wound, Chronic Leg Ulcer
Positive Predictive Value (PPV) of Pseudomonas Aeruginosa
This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are…
- Conditions
- Wound, Chronic Leg Ulcer, Wound Contamination
- Trial name
- NCT03290690
- Where
- Canada
- Volunteers
- 65 people
- Sponsor
- MolecuLight Inc.
Genetic Predisposition to Disease, Inflammation
Gene Expression in Chronic Venous Leg Ulcers
Chronic Venous Disease (CVD) is a widespread clinical condition widely spread in the western countries that may negatively impact the quality of life (QoL) of affected patients.
- Conditions
- Genetic Predisposition to Disease, Inflammation, Venous Leg Ulcer
- Trial name
- GECVELUS (NCT05134597)
- Testing
- Genetic assessment
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
Chronic Leg Ulcers, Wound Healing
Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing.
- Trial name
- NCT00825760
- Testing
- Topical PPA904 gel and light
- Where
- 4 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- Photopharmica
Lymphedema
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic…
- Trial name
- NCT01079299
- Testing
- Intermittent, gradient, pneumatic compression device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Calvary Hospital, Bronx, NY
Diabetic Foot Ulcer
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
- Trial name
- VHTDFU2 (NCT04210609)
- Testing
- Vaporous Hyperoxia Therapy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vaporox
Venous Insufficiency, Leg Ulcer
THERMES ET VEINES: Spa for Prevention of Leg Ulcers
The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous insufficiency (C4a-b and C5 of the CEAP…
- Conditions
- Venous Insufficiency, Leg Ulcer, Varicose Ulcer
- Trial name
- NCT00838500
- Testing
- Immediate spa treatment, Late spa treatment
- Where
- 13 sites in France
- Volunteers
- 425 people
- Sponsor
- Association Francaise pour la Recherche Thermale
Diabetic Foot Ulcer
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period.
- Trial name
- DFUMAT (NCT05968924)
- Testing
- Podimetrics SmartMat
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center