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

NCT01537003 | Unknown

• 1 other identifier: SWM1200
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 7

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. Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds

Conditions

Venus Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test

  The primary end-point of this study will be 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 venous leg ulcers will be defined as the proportion of wounds which reach a minimum 30% percentage reduction in wound surface area over a four-week treatment period.

  12 weeks

Secondary Outcomes (1)

• The average percentage change in protease activity levels pre and post treatment

  12 weeks

Study Arms (4)

Promogran and Low EPA

EXPERIMENTAL

Patients with low EPA will be treated with PROMOGRAN and standard of care for vlu compression

Device: Promogran

Low EPA and compression

ACTIVE COMPARATOR

Patients with Low EPA will only get standard of care for VLU which is compression.

Device: Coban 2 layer

High EPA and compression

ACTIVE COMPARATOR

Patients with high EPA will get standard of care for VLU which is compression.

Device: Coban 2 layer

Promogran High EPA

EXPERIMENTAL

patients with HIGH EPA will then be treated with PROMOGRAN and standard of care for VLU compression

Device: Promogran

Interventions

Promogran DEVICE

Promogran is a collagen/ORC dressing which modulates the wound environment

Promogran High EPA; Promogran and Low EPA

Coban 2 layer DEVICE

Compression bandage

High EPA and compression; Low EPA and compression

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 leg ulcers of venous aetiology as determined by ankle brachial pressure index (ABPI) ≥ 0.8 and able and willing to use appropriate compression therapy
• Duration of ulcer ≥ 6 weeks ≤ 3 years
• Ulcer is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm
• 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:

• Leg ulcers that do not have venous aetiology as determined by not been suitable for compression therapy and having an ABPI ≤ 0.8
• Leg ulcer smaller than 1cm2 and larger than 100cm2 and has any length longer than 10cm
• Wound duration of less than 6 weeks or longer than 3 years
• Known hypersensitivity to any of the wound dressing used in the trial
• 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)
• 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)

Sponsors & Collaborators

• Systagenix Wound Management: lead

Study Sites (7)

Penn North Centers for Advance Wound Care

Eire, Pennsylvania, 16544, United States

RECRUITING

University Medical Center Gieben and Marburg GmBH

Marburg, D-35043, Germany

RECRUITING

Dres. Bolko Alter Siamak Pourhassan

Oberhausen, D-46145, Germany

RECRUITING

University of Pisa

Pisa, Roma, 56126, Italy

RECRUITING

University of Ferrara

Ferrara, 44100, Italy

RECRUITING

Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

RECRUITING

Bradford Royal Infirmary

Bradford, Yorkshire, BD9 6RJ, United Kingdom

RECRUITING

Study Officials

• Keith Harding, Prof

  Cardiff University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breda Cullen, PHD

CONTACT

breda.cullen@systagenix.com

Study Design

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

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 8, 2013

Record last verified: 2013-05

Locations

DE (2); US (1); GB (2); IT (2)