Surgical Research

Currently Enrolling Plastic Surgery Studies

Study: Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects with Diabetic Foot Ulcer

Study: The Mechanism of Action of Unite™ Biomatrix in Diabetic Foot Ulcer


Study Title: Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects with Diabetic Foot Ulcer
Sponsor:  Biotest, Inc.
Principal Investigator: John Steinberg, DPM

Purpose

The purpose of this study is to assess if the experimental topical drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.

Intervention

Drug: NorLeu3-A(1-7) in a gel formulation

Detailed Description

Subjects (patients who sign a consent form) will be assessed after a 14-day screening period to evaluate ulcer healing to ensure diabetic ulcers are chronic. If it is determined that the ulcer is chronic, subjects will be randomized or assigned (like tossing a coin) to one of three treatment groups:

  1. Placebo (gel without an active ingredient)
  2. Study topical gel with 0.03 % of the active ingredient of DSC127
  3. Study topical gel with 0.01% of the active ingredient of DSC127

Subjects will be treated weekly for 4 weeks, followed by 8 weeks of clinical observation and assessment of the diabetic foot ulcer.. If wound healing occurs during the active treatment or observation periods a final assessment visit will be done and the status of the healed ulcer will assessed four and twelve weeks later (usually weeks 16 and 24 of the study).

Eligibility

Age 18 years or older & diagnosed with chronic non-healing Diabetic foot ulcer

For more information regarding eligibility, please see ClinicalTrials.gov  Use Clinical Trials.gov Identifier: NCT00796744

Or

Call Susan Borgiasz RN 202-444-7288 or Mitra Aminrazavi, CRC 202-444-6735


Study Title: The Mechanism of Action of Unite™ Biomatrix in Diabetic Foot Ulcer
Protocol Number: U0801
Version Date: Amendment 3
Principle Investigator: Dr. John Steinberg
Sponsor: SYNOVIS ORTHOPEDIC & WOUNDCARE
Status: Enrolling Patients

Purpose:

To understand how Unite Biomatrix helps to heal Diabetic Foot Ulcers and to compare it’s effectiveness to saline moistened gauze which is a standard treatment for Diabetic Foot Ulcers

General Eligibility

You must be 18 years old, diagnosed with Diabetic Foot Ulcer for more than 4 weeks

Device

The Unite Biomatrix dressing is derived from a horse’s heart sac and is used to heal skin surface wounds.

Study Visits

A baseline screening visit 30 days prior to surgery, a pre-treatment visit (7 days prior to treatment), 12 weekly visits following treatment, a 6 month visit will be required. The Unite Biomatrix will be applied directly following the second debridement. An additional Unite Biomatrix may be applied during a follow-up visit if necessary.

To inquire about the study please contact

Rhonda Cornell, DPM at 202-444-1784

Susan Borgiasz, RN at 202-444-7288