Clinical trials: Chronic Diabetic Foot Ulcers
Chronic Wound, Venous Leg Ulcer
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03662997
- Testing
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing, Hydrocellular Multi-Layer Foam Dressing
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Molnlycke Health Care AB
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
Diabetes Mellitus, Diabetic Foot Ulcer
Evaluation of 3D Imaging Ulcer Camera
The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection).
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer, Wound, Chronic Disease
- Trial name
- 3D-DFU (NCT03063138)
- Where
- Denmark
- Volunteers
- 48 people
- Sponsor
- Odense University Hospital
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 Ulcer
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
- Trial name
- FEENICS (NCT00662831)
- Testing
- Fragmin/ Dalteparin Sodium
- Where
- 63 sites in Austria, Belgium and 15 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Diabetic Foot Ulcer
Pilot Study of PHOENIX Wound Matrix® Impact on Chronic DFU Wound Microbiome
A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers
- Trial name
- NCT04437537
- Testing
- Bioresorbable 3D electrospun synthetic matrix
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- RenovoDerm
Diabetic Foot Ulcer, Diabetic Foot
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery
Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer Neuropathic
- Trial name
- DiabeticMIS1 (NCT03010215)
- Testing
- Distal Metatarsal Minimally invasive Osteotomy (DMMO)
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- University of Padova
Chronic Diabetic Foot Ulcers
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
The purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of a chronic plantar foot ulcer…
- Trial name
- NCT00366132
- Testing
- Extracorporeal Shockwaves
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tissue Regeneration Technologies
Diabetes Mellitus, Claudication, Intermittent
Additional Hyperbaric Oxygen After Lower Extremity Amputation
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
Diabetic Foot Ulcers, Venous Stasis Ulcer
Cellular and Tissue Based Therapy Registry
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these…
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Chronic Non Healing Wound
- Trial name
- CTPR (NCT02322554)
- Testing
- Cellular and tissue based products
- Where
- United States
- Volunteers
- 50,000 people
- Sponsor
- U.S. Wound Registry
Chronic Diabetic Foot Ulcer
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
This study will be a randomized, open-label, pretest post-test with two study groups.
- Trial name
- NCT05849701
- Testing
- Shock wave therapy, Vacuum-assisted closure
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Cairo University
Chronic Wounds With Different Etiologies
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of…
- Trial name
- NCT01750203
- Testing
- Swabs
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Chronic Diabetic Foot Ulcers
Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds
The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics.
- Trial name
- NCT02098447
- Testing
- PrimeStim
- Where
- Austria
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Chronic Diabetic Foot Ulcers
Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
- Trial name
- NCT04962139
- Testing
- ON101 Cream, Vehicle Cream
- Where
- 14 sites in United States
- Volunteers
- 12 people
- Sponsor
- Oneness Biotech Co., Ltd.
Chronic Wounds, Diabetic Foot Ulcer
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers.
- Conditions
- Chronic Wounds, Diabetic Foot Ulcer, Venous Leg Ulcers, Arterial Ulcer
- Trial name
- DEXPAN-WOUND (NCT07395674)
- Testing
- Dexpanthenol, Standard Wound Care
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Dilara CANBAY OZDEMIR
Diabetic Foot Ulcer
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85…
- Trial name
- NCT06584617
- Testing
- Berovenal®, NU-GEL Hydrogel with Alginate
- Where
- 9 sites in Germany, Poland
- Volunteers
- 66 people
- Sponsor
- VULM s.r.o.
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.