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

Primary Purpose

Venus Leg Ulcers

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Promogran

Coban 2 layer

About this trial

This is an interventional diagnostic trial for Venus Leg Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Penn North Centers for Advance Wound CareRecruiting
University Medical Center Gieben and Marburg GmBHRecruiting
Dres. Bolko Alter Siamak PourhassanRecruiting
University of PisaRecruiting
University of FerraraRecruiting
Cardiff UniversityRecruiting
Bradford Royal InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Promogran and Low EPA

Low EPA and compression

High EPA and compression

Promogran High EPA

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The proportion of wounds achieving wound closure (defined as a restoration of a complete epithelial cover) at twelve weeks and the average time to wound closure. The relative cost effectiveness of both treatment regimes when they are targeted appropriately; PROMOGRAN®, a protease modulating therapy targeted to wounds with EPA and standard of care to wounds with LPA.Healing outcomes for standard of care on EPA wounds as compared to LPA wounds. Healing outcomes for PROMOGRAN®, a protease modulating therapy on EPA wounds as compared to LPA wounds.

Full Information

NCT ID

NCT01537003

First Posted

February 16, 2012

Last Updated

July 4, 2013

Sponsor

Systagenix Wound Management

1. Study Identification

Unique Protocol Identification Number

NCT01537003

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Systagenix Wound Management

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

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. Wounds with EPA will be determined using a new POC diagnostic test, WOUNDCHEK™ Protease Status, and the efficacy of PROMOGRAN®, a protease modulating therapy will be determined against standard of care (moist wound healing and compression) in VLU wounds in both elevated EPA and low protease activity wounds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venus Leg Ulcers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Promogran and Low EPA

Arm Type

Experimental

Arm Description

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

Arm Title

Low EPA and compression

Arm Type

Active Comparator

Arm Description

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

Arm Title

High EPA and compression

Arm Type

Active Comparator

Arm Description

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

Arm Title

Promogran High EPA

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Promogran

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Coban 2 layer

Intervention Description

Compression bandage

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Breda Cullen, PHD

breda.cullen@systagenix.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keith Harding, Prof

Organizational Affiliation

Cardiff University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn North Centers for Advance Wound Care

City

Eire

State/Province

Pennsylvania

ZIP/Postal Code

16544

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tom Serena, MD

Phone

814-452-7878

serena@serenagroups.com

First Name & Middle Initial & Last Name & Degree

Sharon McConnell

Phone

(814) 452-7878

smcconnell@serenagroups.com

First Name & Middle Initial & Last Name & Degree

Tom Serena, MD

Facility Name

University Medical Center Gieben and Marburg GmBH

City

Marburg

ZIP/Postal Code

D-35043

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan Skrzypek, MD

Phone

(49) 064215866475

skrzypek@med.uni-marburg.de

First Name & Middle Initial & Last Name & Degree

Jan Skrzypek, MD

Facility Name

Dres. Bolko Alter Siamak Pourhassan

City

Oberhausen

ZIP/Postal Code

D-46145

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siamak Pourhassan, MD

Phone

49 (0)208668898

pourhassan@bdc.de

First Name & Middle Initial & Last Name & Degree

Siamak Pourhassan, MD

Facility Name

University of Pisa

City

Pisa

State/Province

Roma

ZIP/Postal Code

56126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marco Romanelli, MD PHD

Phone

39050992436

m.romanelli@med.unipi.it

First Name & Middle Initial & Last Name & Degree

marco Romanelli, MD PHD

Facility Name

University of Ferrara

City

Ferrara

ZIP/Postal Code

44100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paolo Zamboni, MD

Phone

390532236524

zambo@unife.it

First Name & Middle Initial & Last Name & Degree

Paolo Zamboni, MD

Facility Name

Cardiff University

City

Cardiff

State/Province

Wales

ZIP/Postal Code

CF14 4XN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keith Harding, Prof

Phone

02920744345

hardingkg@cardiff.ac.uk

First Name & Middle Initial & Last Name & Degree

Nicky Ivins

Phone

02920744345

ivinsnm@cf.ac.uk

First Name & Middle Initial & Last Name & Degree

Keith Harding, MD

Facility Name

Bradford Royal Infirmary

City

Bradford

State/Province

Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wendy Jepson

Phone

01274383913

Wendy.Jepson@bthft.nhs.uk

First Name & Middle Initial & Last Name & Degree

kath Vowden

12. IPD Sharing Statement

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

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