Recruiting

WOUNDCHEK™ Test

Sponsor:

Systagenix Wound Management

Code:

NCT01537003

Conditions

Venus Leg Ulcers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Promogran

Coban 2 layer

Study Details

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

Study ID

NCT01537003

Start date

Oct, 2012

Status verified date

May, 2013

Completion date

Jan, 2014

Anticipated

Primary completion date

Oct, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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
  • Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion

Exclusion Criteria:

  • 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
  • Current local or systemic antibiotics in the week prior to inclusion
  • 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)
  • Subject has viral hepatitis

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Promogran and Low EPA

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

active comparator: Low EPA and compression

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

active comparator: High EPA and compression

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

experimental: Promogran High EPA

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

Interventions

Promogran

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

Coban 2 layer

Compression bandage

Primary outcome measure

  • The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Breda Cullen, PHD

breda.cullen@systagenix.com

Locations

Penn North Centers for Advance Wound Care

Recruiting

Eire, Pennsylvania, United States, 16544

Contacts

Tom Serena, MD

814-452-7878serena@serenagroups.com

Sharon McConnell

(814) 452-7878smcconnell@serenagroups.com

Principal Investigator:

Tom Serena, MD

More Information

Sponsor

Systagenix Wound Management

Last update posted

Jul 8, 2013

Last verified

May, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Systagenix Wound Management on 2013-07-08.