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

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01537016
• Other study ID #: SWM1215
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2012
• Last updated: July 4, 2013
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: May 2013
• Source: Systagenix Wound Management
• Contact: Breda Cullen, PHD
• Phone: 01756747510
• Email: breda.cullen[@]systagenix.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer

Intervention

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

Locations

Country	Name	City	State
Germany	Diabetes Klinik Bad Mergentheim Gmbh&CO. KG	Bad Mergentheim
Italy	University of Pisa	Pisa
Spain	Clinica Universitaria de Podologia	Madrid
United Kingdom	Bradford Royal Infirmary	Bradford	Yorkshire
United States	Penn North Centers for advance wound care	Eire	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Systagenix Wound Management

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reduction in wound area and cost effectiveness	The relative reductions in wound surface area from baseline over twelve weeks of treatment.	12 weeks	No