Clinical trials: Chronic Ulcers of the Lower Limb
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Wounds, Wound of Skin
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up.
- Conditions
- Wounds, Wound of Skin, Wound Leg, Wound; Foot
- Trial name
- NCT05588583
- Testing
- Mepilex Up
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- Molnlycke Health Care AB
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.
Venous Ulcer
Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds.
- Trial name
- NCT00998673
- Testing
- Silica Gel Fiber, Standard-of-Care
- Where
- 14 sites in Germany
- Volunteers
- 121 people
- Sponsor
- Bayer
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
Wound Infection Bacterial, Ulcer Foot
Wound Infection Detection Evaluation, WIDE
Chronic wounds, such as diabetic foot ulcers, place a huge burden on healthcare systems and can lead to complications with high morbidity, particularly if the wound if infected.
- Conditions
- Wound Infection Bacterial, Ulcer Foot, Diabetic Foot, Diagnostic Self Evaluation
- Trial name
- WIDE (NCT03883230)
- Testing
- GLYWD
- Where
- United Kingdom
- Volunteers
- 256 people
- Sponsor
- Cumbria Partnership NHS Foundation Trust
Venous Leg Ulcer, Leg Injuries and Disorders
Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers…
- Trial name
- CLEANVLU (NCT04956900)
- Testing
- Aurase Wound gel
- Where
- 8 sites in United States, Hungary and 1 more
- Volunteers
- 43 people
- Sponsor
- SolasCure Limited
Diabetic Foot, Critical Limb Ischemia
Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia
In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the…
- Trial name
- August2 (NCT01638585)
- Testing
- urokinase
- Where
- 18 sites in Germany
- Volunteers
- 34 people
- Sponsor
- GWT-TUD GmbH
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Venous Ulcer
Clinical Effectiveness of Topical Autologous Platelet Gel for the Treatment of Venous Ulcers
The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood.
- Trial name
- NCT00273234
- Testing
- Autologous Platelet Gel (APG)
- Where
- 6 sites in United States
- Volunteers
- 70 people
- Sponsor
- National Healing Corporation
Foot Ulcer, Diabetic, Diabetic Angiopathies
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
- Trial name
- NCT00399425
- Testing
- bemiparin (low molecular weight heparin)
- Volunteers
- 84 people
- Sponsor
- Spanish National Health System
Diabetic Foot Ulcer, Diabetes Mellitus
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat…
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Diabetic Foot, Diabetic Foot Infection
- Trial name
- NCT05610865
- Testing
- Control; Standard-of-care management, Only PRP injection, PRP + SVF injection
- Where
- Pakistan
- Volunteers
- 28 people
- Sponsor
- University of the Punjab
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.
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
Diabetic Foot Ulcer, Diabetic Foot Infection
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.
- Trial name
- NM2023 (NCT06667752)
- Testing
- Advanced Antibacterial Wound Dressing, Aquacel Ag+ Extra
- Where
- 11 sites in Estonia, Spain
- Volunteers
- 136 people
- Sponsor
- Nanordica Medical OU
Chronic Venous Insufficiency, CVI, Venous Malformations
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the…
- Conditions
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome
- Trial name
- HIFIVE (NCT06642051)
- Testing
- High Intensity focused ultrasound
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sonablate
Diabetic Foot, Peripheral Arterial Disease
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult.
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- DM PAD (NCT05009602)
- Testing
- Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI), Exercise Ankle Brachial Pressure Index (ABPI)
- Where
- 17 sites in United Kingdom
- Volunteers
- 604 people
- Sponsor
- Imperial College London
Lower Leg Wound
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
- Trial name
- WoundWand (NCT01924806)
- Testing
- WoundWand™ Debridement Device, Standard of Care sharp debridement
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 11 people
- Sponsor
- Smith & Nephew, Inc.
Charcot Joint of Foot, Osteoarthropathy
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and…
- Trial name
- CHARQUAM (NCT05491577)
- Testing
- Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
- Where
- 17 sites in France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Wound Care, Venous Ulcer Care
Effect of Prontosan Wound Irrigation Solution on Venous Ulcers
Objective: To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution Methodology: Randomised, controlled…
- Conditions
- Wound Care, Venous Ulcer Care, Wound Cleansing, Chronic Wound Care
- Trial name
- NCT01048307
- Testing
- Prontosan wound irrigation solution
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Calvary Hospital, Bronx, NY