Clinical trials: Diabetic Ulcers
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
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
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
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.
Type II Diabetes
Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
The primary objective of this study is to compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.
- Trial name
- NCT02015910
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Georgetown University
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
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.
Diabetic Foot
Less Infections for the Diabetic Foot
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1.
- Trial name
- NCT03615807
- Testing
- Surgical debridement (if needed), Microbiological sampling, Revascularisation (if needed).
- Where
- Switzerland
- Volunteers
- 182 people
- Sponsor
- University Hospital, Geneva
Neuropathic Diabetic Ulcer - Foot
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus…
- Trial name
- NCT01060670
- Testing
- Integra® Dermal Regeneration Template, Conventional Wound Therapy
- Where
- 33 sites in United States, Netherlands Antilles
- Volunteers
- 545 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
The purpose of this study was to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers.
- Trial name
- NCT01645891
- Testing
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Where
- 33 sites in United States
- Volunteers
- 146 people
- Sponsor
- Electrochemical Oxygen Concepts, Inc.
Diabetic Foot Ulcer, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Diabetic Foot Ulcer, Diabetes Mellitus
CSTC1 for Diabetic Foot Ulcers Phase II Study
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Trial name
- NCT01813305
- Testing
- CSTC1, CSTC1 Matched vehicle
- Where
- Taiwan
- Volunteers
- 124 people
- Sponsor
- Charsire Biotechnology Corp.
Diabetes
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
- Trial name
- NCT02211495
- Testing
- GEKO device, Best Medical Therapy
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London