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

Not Applicable

• Conditions: Diabetic Foot Ulcers
• Interventions: Device: Tielle; Device: PROMOGRAN

• Registration Number: NCT01537016
• Lead Sponsor: Systagenix Wound Management

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Status Verified: 2013-05
• Study Start: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High EPA and standrad of care	Tielle	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
Promogran and Low EPA	PROMOGRAN	Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care
Low EPA and standard of care	Tielle	Low EPA wounds will be treated with the standard of care for diabetic foot ulcers.
Promogran and High EPA	PROMOGRAN	Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care

Primary Outcome Measures

Name	Time	Method
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.	4 weeks	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

Name	Time	Method
Reduction in wound area and cost effectiveness	12 weeks	The relative reductions in wound surface area from baseline over twelve weeks of treatment.

Trial Locations

Locations (5)

Diabetes Klinik Bad Mergentheim Gmbh&CO. KG; 🇩🇪 Bad Mergentheim, Germany

Penn North Centers for advance wound care; 🇺🇸 Eire, Pennsylvania, United States

Clinica Universitaria de Podologia; 🇪🇸 Madrid, Spain

Bradford Royal Infirmary; 🇬🇧 Bradford, Yorkshire, United Kingdom

University of Pisa; 🇮🇹 Pisa, Italy