Clinical trials: Diabetic Ulcer
Diabetic Foot Ulcer
GrafixPL PRIME Evaluation Case Study
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL…
- Trial name
- NCT03742440
- Testing
- GrafixPL PRIME
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcers
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
- Trial name
- NCT00605189
- Testing
- Powered Suction Pump (VAC Freedom), Powered Suction Pump, MWT
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Wound Heal, Peripheral Artery Disease
Safety and Efficacy of the Noxsano Wound Care Bandage
This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity…
- Conditions
- Wound Heal, Peripheral Artery Disease, Ulcer, Leg, Ulcer Foot
- Trial name
- NCT04123093
- Testing
- Noxsano Bandage (Healthy Volunteers), Noxsano Bandage (Wound Care)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- OhioHealth
Diabetic Foot Ulcers
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition is more frequent in elder patients.
- Trial name
- NCT02789033
- Testing
- Chitosan, Isosorbide dinitrate
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of Guadalajara
Diabetic Foot Ulcers
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in…
- Trial name
- ITCC (NCT01221207)
- Testing
- Total Contact Cast, Instant Total Contact Cast (ITCC), Removable Cast Walker (RCW)
- Where
- 4 sites in United States
- Volunteers
- 225 people
- Sponsor
- University of Texas Southwestern Medical Center
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
OASIS Wound Matrix (Oasis) Mechanism of Action
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
- Trial name
- NCT00570141
- Testing
- OASIS Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Healthpoint
Diabetic Foot
Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma…
- Trial name
- NCT01199783
- Testing
- Daptomycin, Vancomycin
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Ruhr University of Bochum
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.
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-2 (NCT02447172)
- Testing
- Gentamicin Collagen sponge
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 524 people
- Sponsor
- Innocoll
Diabetic Foot Ulcers, Diabetic Foot Wounds
Wound Edge Changes Following Treatment With Santyl
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.
- Trial name
- NCT01197898
- Testing
- Collagenase Santyl Ointment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer, Diabetes Mellitus, Type 2
Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers
People with diabetes are at risk for life altering complications, including diabetic foot ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing weight on their affected limb for months.
- Trial name
- NCT03002155
- Testing
- EnhanceFitness community exercise program
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Washington
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-North (NCT01217476)
- Testing
- Trafermin 0.01% spray
- Where
- 37 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 207 people
- Sponsor
- Olympus Biotech Corporation
Foot Ulcer, Diabetic
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.
- Trial name
- NCT02647346
- Testing
- Daily use of podimetrics smart-foot mat
- Where
- 8 sites in United States
- Volunteers
- 132 people
- Sponsor
- Podimetrics, Inc.
Diabetic Foot Ulcer
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.
- Trial name
- DULCIS (NCT02677779)
- Testing
- CO2 laser, traditional surgery
- Volunteers
- 20 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Diabetic Foot Ulcer
Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement.
- Trial name
- NCT04633642
- Testing
- Ultrasound group, Surgical group
- Where
- 2 sites in Spain
- Volunteers
- 51 people
- Sponsor
- Universidad Complutense de Madrid
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers…
- Trial name
- NCT03547635
- Testing
- AMNIOEXCEL Plus Amniotic Membrane, A Marketed Comparator, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 116 people
- Sponsor
- Integra LifeSciences Corporation
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-1 (NCT02427802)
- Testing
- Gentamicin collagen sponge
- Where
- 86 sites in United States
- Volunteers
- 612 people
- Sponsor
- Innocoll