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

NCT01537016 | Unknown

• 1 other identifier: SWM1215
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in wound area and cost effectiveness

  12 weeks

Study Arms (4)

Promogran and High EPA

EXPERIMENTAL

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

Device: PROMOGRAN

Promogran and Low EPA

EXPERIMENTAL

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

Device: PROMOGRAN

High EPA and standrad of care

ACTIVE COMPARATOR

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

Low EPA and standard of care

ACTIVE COMPARATOR

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

Device: Tielle

Interventions

PROMOGRAN DEVICE

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

Promogran and High EPA; Promogran and Low EPA

Tielle DEVICE

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

High EPA and standrad of care; Low EPA and standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Wound duration of less than 6 weeks or longer than 2 years
• Known hypersensitivity to any of the wound dressing used in the trial
• 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

Sponsors & Collaborators

• Systagenix Wound Management: lead

Study Sites (5)

Penn North Centers for advance wound care

Eire, Pennsylvania, 16544, United States

RECRUITING

Diabetes Klinik Bad Mergentheim Gmbh&CO. KG

Bad Mergentheim, 97980, Germany

RECRUITING

University of Pisa

Pisa, 56126, Italy

RECRUITING

Clinica Universitaria de Podologia

Madrid, Spain, Spain

RECRUITING

Bradford Royal Infirmary

Bradford, Yorkshire, BD9 6RJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Keith Harding, Prof

  Cardiff University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breda Cullen, PHD

CONTACT

01756747510; breda.cullen@systagenix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 8, 2013

Record last verified: 2013-05

Locations

ES (1); GB (1); US (1); DE (1); IT (1)