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

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Diabetic Foot Ulcers

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: PROMOGRAN; Device: Tielle

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Breda Cullen, PHD; Phone Number: 01756747510; Email: breda.cullen@systagenix.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in wound area and cost effectiveness	The relative reductions in wound surface area from baseline over twelve weeks of treatment.	12 weeks

Collaborators and Investigators

• Sponsor: Systagenix Wound Management
• Investigators: Principal Investigator: Keith Harding, Prof, Cardiff University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): August 1, 2013
• Study Completion (ANTICIPATED): August 1, 2013

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (ESTIMATE): February 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 4, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: SWM1215