Clinical trials: Ulcer, Leg
Diabetic Foot, Wound
Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.
- Trial name
- NCT04042285
- Testing
- Extracorporeal shockwave therapy in addition to standard care
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Diabetic Foot Ulcers
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
- Trial name
- CHEXU 01 (NCT02091778)
- Testing
- Fast gelling dressing
- Where
- 2 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Venous Wound Ulcers
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
- Trial name
- Sorbion (NCT03020446)
- Testing
- Sorbion Dressing
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Toledo Health Science Campus
Diabetic Foot
BE Study of Metformin GSK 500mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study.
- Trial name
- BA/BE 173/11 (NCT01710527)
- Testing
- Metformin 500mg, Glucophage 500mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetic Foot Ulcers
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the…
- Trial name
- NCT01143727
- Testing
- Santyl, Tegaderm Hydrogel
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Healthpoint
Peripheral Arterial Disease, Diabetic Foot
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with…
- Trial name
- DFU-002 (NCT02264288)
- Testing
- PDA-002
- Where
- 45 sites in United States
- Volunteers
- 159 people
- Sponsor
- Celularity Incorporated
Venous Leg Ulcers
A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers
Venous leg ulcers are chronic wounds caused by venous insufficiency, leading to significant morbidity. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I…
- Trial name
- NCT06831760
- Testing
- SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Dr Naveen Narayan MS, MCh (Plastic Surgery)
Diabetic Foot Ulcers
TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
- Trial name
- MxT Ag 05 (NCT01964521)
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United Kingdom
- Volunteers
- 24 people
- Sponsor
- Molnlycke Health Care AB
Skin Ulcers, Sickle Cell Anemia
Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II.
- Trial name
- NCT00004412
- Testing
- Arginine Butyrate, Standard local care dressing
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Susan P. Perrine
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Chronic Foot Ulcers
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.
- Trial name
- NCT01472432
- Testing
- vildagliptin
- Where
- Italy
- Volunteers
- 106 people
- Sponsor
- University of Campania Luigi Vanvitelli
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer
VLU Dressing Study
The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).
- Trial name
- NCT03621592
- Testing
- Cutimed® Sorbact®, Acticoat®
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Miami
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
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
Diabetic Foot, Diabetic Foot Ulcer
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg
- Trial name
- NCT05579743
- Testing
- Remote wound monitoring technology
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Johns Hopkins University
Pressure Ulcer, Soft Tissue Necrosis Lower Limb
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.
- Trial name
- NCT01208220
- Testing
- Negative Pressure Wound Therapy, Collagenase Ointment
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center Shreveport
Diabetic Foot Ulcer
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
- Trial name
- NCT03624023
- Testing
- TWB-103
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- Transwell Biotech Co., Ltd.
Venous Leg Ulcer
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Trial name
- NCT02104180
- Testing
- Urgotul, TulleGras M.S.
- Where
- 27 sites in France
- Volunteers
- 62 people
- Sponsor
- Mylan Inc.