WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Systagenix Wound Management
Sponsor:
Information provided by (Responsible Party):
Systagenix Wound Management
ClinicalTrials.gov Identifier:
NCT01537016
First received: February 16, 2012
Last updated: July 4, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcers
Device: PROMOGRAN
Device: Tielle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Systagenix Wound Management:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    An improved healing outcome for diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period.


Secondary Outcome Measures:
  • Reduction in wound area and cost effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The relative reductions in wound surface area from baseline over twelve weeks of treatment.


Estimated Enrollment: 250
Study Start Date: July 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: 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
Experimental: Promogran and Low EPA
Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care
Device: 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
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
Device: Tielle
Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing
Active Comparator: Low EPA and standard of care
Low EPA wounds will be treated with the standard of care for diabetic foot ulcers.
Device: Tielle
Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537016

Contacts
Contact: Breda Cullen, PHD 01756747510 breda.cullen@systagenix.com

Locations
United States, Pennsylvania
Penn North Centers for advance wound care Recruiting
Eire, Pennsylvania, United States, 16544
Contact: Dr Tom Serena, MD    814-452-7878    serena@serenagroups.com   
Contact: Sharon McConnell    (814) 452-7878    smcconnell@serenagroups.com   
Principal Investigator: Tom Serena, MD         
Germany
Diabetes Klinik Bad Mergentheim Gmbh&CO. KG Recruiting
Bad Mergentheim, Germany, 97980
Contact: Karl Zink, MD    0049 (0)7931594139    zink@diabetes-zentrum.dewww   
Principal Investigator: Karl Zink, MD         
Italy
University of Pisa Recruiting
Pisa, Italy, 56126
Contact: Alberto Piaggesi, Prof    050992436    a.piaggesi@ao-pisa.toscana.it   
Principal Investigator: Alberton Piaggesi, MD         
Spain
Clinica Universitaria de Podologia Recruiting
Madrid, Spain
Contact: Yolanda Alvarez, MD    34 (91) 3942203    yolienf3@hotmail.com   
Principal Investigator: Jose Luis Martinez, Prof         
United Kingdom
Bradford Royal Infirmary Recruiting
Bradford, Yorkshire, United Kingdom, BD9 6RJ
Contact: Wendy Jepson    01274383913    Wendy.Jepson@bthft.nhs.uk   
Principal Investigator: Kath Vowden         
Sponsors and Collaborators
Systagenix Wound Management
Investigators
Principal Investigator: Keith Harding, Prof Cardiff University
  More Information

No publications provided

Responsible Party: Systagenix Wound Management
ClinicalTrials.gov Identifier: NCT01537016     History of Changes
Other Study ID Numbers: SWM1215
Study First Received: February 16, 2012
Last Updated: July 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014