Clinical trials: Foot Ulcers, Diabetic
Diabetic Foot Ulcers
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
- Trial name
- NCT02209051
- Testing
- AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.
- Trial name
- NCT01427569
- Testing
- IZN-6D4 Gel
- Where
- Israel
- Volunteers
- 82 people
- Sponsor
- Izun Pharma Ltd
Diabetic Foot, Diabetic Foot Ulcer
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Trial name
- NCT06035536
- Testing
- Symphony™ plus Off-loading, Wound Dressing comprising of calcium alginate Fibracol
- Where
- 11 sites in United States
- Volunteers
- 143 people
- Sponsor
- Aroa Biosurgery Limited
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
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.
Diabetes, Ulceration
Shear and Pressure Reducing Insoles for the Diabetic Foot
We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear.
- Conditions
- Diabetes, Ulceration, Amputation, Foot Deformity
- Trial name
- GlideSoft (NCT00499356)
- Testing
- pressure reducing insole, GlideSoft®
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- Diabetica Solutions Inc.
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Diabetic Foot Ulcer
Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)…
- Trial name
- NCT05687656
- Testing
- InnovaMatrix AC porcine placental ECM therapy
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer
Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised treatment, over a 16 week period conducted at out-patient level, utilising novel optical wound measurement technologies.
- Trial name
- NCT02967900
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Michelson Diagnostics Ltd.
Diabetic Foot Ulcer
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers.
- Trial name
- NCT06531512
- Testing
- Xianglei Tangzu Gao, Vehicle Cream
- Where
- 14 sites in China
- Volunteers
- 120 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer, Venous Leg Ulcer
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Ulcer Foot, Leg Ulcer
- Trial name
- NCT06560502
- Testing
- Standard of Care-DFU, AmnioCore - DFU, Amnio Quad-Core - DFU
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Stability Biologics
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
- Trial name
- NCT06141811
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- 4 sites in South Korea
- Volunteers
- 104 people
- Sponsor
- Anterogen Co., Ltd.
Non Healing Diabetic Foot Ulcer
Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care
This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm.
- Trial name
- WAR (NCT04207099)
- Testing
- MolecuLight i:X Imaging Device
- Where
- 3 sites in United States
- Volunteers
- 61 people
- Sponsor
- MolecuLight Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and…
- Trial name
- CAMPLIFE (NCT06562296)
- Testing
- Amnion-Intermediate-Chorion, Amnion-Chorion-Amnion, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 292 people
- Sponsor
- Cellution Biologics
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 Ulcer, Diabetic Foot
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer, Diabetic
- Trial name
- CAMPAIGN (NCT06600724)
- Testing
- Standard of Care, EPIEFFECT, EPIXPRESS
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot
FeetSee Thermal Images Collection Protocol
The purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of…
- Trial name
- NCT05222490
- Testing
- Thermal Camera images acquisition - FeetSee, Thermal Camera images acquisition - Reference
- Where
- Lithuania
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Diabetis JSC
Diabetic Foot Ulcer
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
- Trial name
- NCT05046158
- Testing
- Transforming Powder Dressing, Standard of care topical wound agents and dressings
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- ULURU Inc.