Clinical Trials Logo
  1. Home
  2. Foot Ulcer, Diabetic
  3. NCT01858545

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title:
An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial

Clinical Trial Summary

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Clinical Trial Description

Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01858545
Study type Interventional
Source Integra LifeSciences Corporation
Contact
Status Terminated
Phase N/A
Start date May 2013
Completion date December 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03942081 - Diabetic Foot Ulcer Imaging- Study 2 N/A
Not yet recruiting NCT06023810 - The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers N/A
Recruiting NCT02838784 - Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers N/A
Terminated NCT01729286 - Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix N/A
Completed NCT01699100 - Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design N/A
Completed NCT05908968 - Assessing the Effects of ELO Water on Diabetic Foot Ulcers N/A
Recruiting NCT05586542 - Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers Phase 1
Completed NCT02581488 - Use of Santyl in Diabetic Foot Ulcers Phase 4
Completed NCT02334241 - The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study) N/A
Completed NCT01956162 - Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients N/A
Completed NCT00796744 - Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers Phase 2
Recruiting NCT04210089 - Total Contact Soft Cast in Diabetic Foot Ulcers N/A
Completed NCT02647346 - In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers N/A
Completed NCT01480362 - Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds N/A
Terminated NCT01013792 - A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers N/A
Completed NCT01580917 - Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study N/A
Completed NCT02427802 - Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers Phase 3
Completed NCT02451722 - Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear N/A
Completed NCT00516958 - Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections Phase 2
Completed NCT03135535 - Micro-mobile Foot Compression and Diabetic Foot Phase 2