Recruiting

WOUNDCHEK™

Sponsor:

Systagenix Wound Management

Code:

NCT01537016

Conditions

Diabetic Foot Ulcers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PROMOGRAN

Tielle

Study Details

Brief summary:

The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.

It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.

Conditions

Diabetic Foot Ulcers

Study ID

NCT01537016

Start date

Jul, 2013

Status verified date

May, 2013

Completion date

Aug, 2013

Anticipated

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and women aged ≥ 18 years old
  • Patients with a diabetic foot ulcer as defined by Wagner grade 1 - 2
  • ABPI of ≥0.6 to ensure ischemia will not impact healing
  • No restriction on wound size or wound location
  • Duration of ulcer ≥ 6 weeks ≤ 2 years
  • The patient must be able to understand the trial and provide written informed consent
  • No local or systemic signs of infection, with normal CRP and leukocyte levels below 10 000
  • Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion

Exclusion Criteria:

  • Wound duration of less than 6 weeks or longer than 2 years
  • Known hypersensitivity to any of the wound dressing used in the trial
  • Current local or systemic antibiotics in the week prior to inclusion
  • Patients with significant ischemia as defined by ABPI of ≤0.6
  • Clinical infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema.
  • Progressive neoplastic lesion treated by radiotherapy or chemotherapy
  • Prolonged treatment with immunosuppressive agents or high dose corticosteroids
  • Patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
  • Patients with renal insufficiency (with eGFR values <30 or on RRT) Life expectancy of <6 months
  • Patients with uncontrolled diabetes as determined by Hb-A1c ≥ 12% ( = Hb-1CIFCC ≥ 107.65 mmol/mol)
  • Patients who have participated in a clinical trial on wound healing within the past month
  • Patients who are unable to understand the aims and objectives of the trial
  • Patients with a known history of non adherence with medical treatment
  • Females who are pregnant
  • Subject has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV)
  • Subject has viral hepatitis

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Promogran and High EPA

Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care

experimental: Promogran and Low EPA

Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care

active comparator: High EPA and standrad of care

Wounds with high EPA will get standard of care as in line with current practice as they is no other test currently available for EPA

active comparator: Low EPA and standard of care

Low EPA wounds will be treated with the standard of care for diabetic foot ulcers.

Interventions

PROMOGRAN

PROMOGRAN® is a protease modulating dressing, formulated as a bioresorbable amorphous open-pored matrix constructed of 45% oxidised regenerated cellulose (ORC) and 55% bovine collagen

Tielle

Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing

Primary outcome measure

  • To identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Breda Cullen, PHD

01756747510breda.cullen@systagenix.com

Locations

Penn North Centers for advance wound care

Recruiting

Eire, Pennsylvania, United States, 16544

Contacts

Dr Tom Serena, MD

814-452-7878serena@serenagroups.com

Sharon McConnell

(814) 452-7878smcconnell@serenagroups.com

Principal Investigator:

Tom Serena, MD

More Information

Sponsor

Systagenix Wound Management

Last update posted

Jul 8, 2013

Last verified

May, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Systagenix Wound Management on 2013-07-08.