Clinical trials: Diabetic Foot Disease
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efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…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.
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
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
Foot Ulcer, Diabetic, Diabetic Foot
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
- Trial name
- NCT00796744
- Testing
- NorLeu3-A(1-7) in a gel formulation
- Where
- 12 sites in United States
- Volunteers
- 78 people
- Sponsor
- US Biotest, Inc.
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
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
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers…
- Trial name
- NCT00659646
- Testing
- gentamicin-collagen sponge and levofloxacin, Levofloxacin only
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Innocoll
Foot Ulcer
A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
This clinical trial aims to learn if a personalized self-care program supporting self-care and Healing through Empowerment and Active Listening (HEALing), is acceptable to patients with diabetic foot ulcer (DFU) and wound care…
- Trial name
- NCT06540170
- Testing
- A personalised self-care support program
- Where
- Singapore
- Volunteers
- 29 people
- Sponsor
- National Healthcare Group Polyclinics
Diabetic Foot Ulcer (DFU)
High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and…
- Trial name
- NCT06470087
- Testing
- SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
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
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
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.
Neuropathic Diabetic Ulcer - Foot
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
- Trial name
- NCT01396837
- Testing
- RedDress Wound Care System (RD1)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.
- Trial name
- NCT06557122
- Testing
- SOC and Advanced Bioengineered Skin Substitute, SOC and Active Comparator
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Encoll Corp
Staphylococcal Skin Infections
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
- Trial name
- NCT00463801
- Testing
- Daptomycin
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Novartis
Foot Ulcer, Diabetic
Pressure Alternating Shoes
The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers.
- Trial name
- PAS (NCT06026813)
- Testing
- test pressure alternating shoes
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcer, Ulcer Foot
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Trial name
- NCT06403605
- Testing
- Mirragen Advanced Wound Matrix, Fibracol
- Where
- 15 sites in United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- ETS Wound Care, LLC
Painful Diabetic Neuropathies
Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy
The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.
- Trial name
- NCT01475786
- Testing
- Low Dose: 16 mg Engensis (VM202), High Dose: 32 mg Engensis (VM202)
- Where
- 17 sites in United States, South Korea
- Volunteers
- 104 people
- Sponsor
- Helixmith Co., Ltd.