Clinical trials: Diabetic Foot Ulcer
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South 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-South (NCT01217463)
- Testing
- Trafermin 0.01% spray
- Where
- 24 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Olympus Biotech Corporation
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-1 (NCT01590758)
- Testing
- Topical pexiganan cream 0.8%, Standard wound care
- Where
- 30 sites in United States
- Volunteers
- 189 people
- Sponsor
- Dipexium Pharmaceuticals, Inc.
Diabetes Complications
Abnormal Plantar Pressure in Patients With Diabetes
The prevalence of abnormal plantar pressure distribution (APD) and its connection with various factors among patients with diabetes is not known.
- Trial name
- NCT03426566
- Testing
- retrospective observational study with no intervention
- Where
- Poland
- Volunteers
- 974 people
- Sponsor
- Wroclaw Medical University
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 Ulcers
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).
- Trial name
- CHEXU 01 (NCT02091778)
- Testing
- Fast gelling dressing
- Where
- 2 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US.
- Trial name
- NCT03476876
- Testing
- Dermacell, Integra
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Baylor College of Medicine
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
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
Infection; Diabetic Foot
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections.
- Trial name
- NCT01370616
- Testing
- Ertapenem sodium, Piperacillin/tazobactam sodium, Amoxicillin/clavulunate potassium
- Volunteers
- 565 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Diabetic Foot Ulcer, Non-healing Wound
Debritom - Micro Water Jet Technology and Wound Healing
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer
- Trial name
- NCT04240574
- Testing
- Debritom
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Stephanie Wu
Diabetic Foot Ulcers
Negative Pressure Wound Therapy as a Drug Delivery System
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous…
- Trial name
- NCT02463487
- Testing
- Cardinal Pro +Simultaneous Irrigation (NPWTi), Cardinal Pro (NPWT) Therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcers
A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers
The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the…
- Trial name
- NCT01143714
- Testing
- Santyl, White Petrolatum
- Where
- 6 sites in United States
- Volunteers
- 57 people
- Sponsor
- Healthpoint
Diabetic Foot, Wound
Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.
- Trial name
- NCT04042285
- Testing
- Extracorporeal shockwave therapy in addition to standard care
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust