Clinical trials: Foot Ulcer, Diabetic
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Diabetic Foot Ulcer
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human…
- Trial name
- NCT04918784
- Testing
- Restrata®, Wound Dressing
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcer
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial…
- Trial name
- NCT00765063
- Testing
- Fragmin
- Where
- 27 sites in Austria, Belgium and 12 more
- Volunteers
- 62 people
- Sponsor
- Pfizer
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcers
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.
- Trial name
- NCT00958711
- Testing
- Unite Biomatrix, Saline and Gauze
- Where
- 11 sites in United States
- Volunteers
- 90 people
- Sponsor
- Baxter Healthcare Corporation
Diabetic Foot Ulcer
PriMatrix for the Management of Diabetic Foot Ulcers
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment.
- Trial name
- NCT03010319
- Testing
- PriMatrix Dermal Repair Scaffold, Secondary Dressings, Offloading device
- Where
- 17 sites in United States
- Volunteers
- 226 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with standard treatments used in the treatment of DFUs.
- Trial name
- NCT00536744
- Testing
- acoustical pulse energy (extracorporeal shockwave)
- Where
- 23 sites in United States, Germany and 1 more
- Volunteers
- 206 people
- Sponsor
- SANUWAVE, Inc.
Diabetic Foot Ulcers
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care…
- Trial name
- NCT00761176
- Testing
- The Provant Therapy System
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, Inc.
Diabetic Foot Infection
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of…
- Trial name
- OneStep-2 (NCT01594762)
- Testing
- Topical pexiganan cream 0.8%, Standard wound care
- Where
- 39 sites in United States
- Volunteers
- 200 people
- Sponsor
- Dipexium Pharmaceuticals, Inc.
Non-healing Wound, Non-healing Diabetic Foot Ulcer
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion…
- Conditions
- Non-healing Wound, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT03230175
- Testing
- TTAX01, Surgical resection and debridement, Systemic antibiotics
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- BioTissue Holdings, Inc
Pressure Ulcer, Leg Ulcer
Evaluation Of An Advanced Borderless Dressing
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03146845
- Testing
- ALLEVYN Life Non-Bordered, Standard Care
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Diabetes Type I, Diabetes Type II
Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment
The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study.
- Trial name
- NCT02184455
- Testing
- DermGEN
- Where
- 2 sites in Canada
- Volunteers
- 11 people
- Sponsor
- Dr. Paul F. Gratzer
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S
Diabetic Foot Ulcer
MIRODERM H2H DFU Study
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
- Trial name
- H2H-DFU (NCT03232333)
- Testing
- Biologic wound graft
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Miromatrix Medical Inc.
Diabetic Foot Ulcers
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
- Trial name
- NCT01353495
- Testing
- APM Graft (BIOTAPE XMTM), Wound Debridement
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Stryker Trauma and Extremities
Diabetic Foot Ulcer
Study of Oasis Ultra in Diabetic Foot Ulcers
Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.
- Trial name
- NCT01835379
- Testing
- Oasis, Standard
- Where
- 16 sites in United States
- Volunteers
- 82 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcers
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT00432965
- Testing
- Moist Wound Therapy, VAC Therapy
- Where
- 25 sites in United States, Canada
- Volunteers
- 335 people
- Sponsor
- KCI USA, 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.