Condition category
Skin and Connective Tissue Diseases
Date applied
13/06/2006
Date assigned
11/08/2006
Last edited
29/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Nixon

ORCID ID

Contact details

Clinical Trials Research Unit
University of Leeds
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

PROtease modulating dressings in the treatment of chronic wounds: finding bioMARKers to predict healing response

Acronym

ProMark

Study hypothesis

A chronic leg ulcer is defined as a wound between the knee and ankle joint that has not healed within four weeks. The aim of this study is to identify biomarkers which differentiate between leg ulcer patients whose wounds will and will not respond to treatment with protease modulating dressings.

On 12/02/2008 the overall trial end date was amended and approved; the previous dates are as follows:
Original overall trial start date: 01/09/2006
Original overall trial end date: 30/06/2007
Amended overall trial start date 1 (amended 19/02/2007): 01/03/2007
Amended overall trial end date 1 (amended 19/02/2007): 01/10/2007
The new overall trial start and end dates have been added to the relevant fields.

Ethics approval

Ethical approval for original protocol received from the Leeds (West) Research Ethics Committee on the 07/09/2006 (ref: 06/Q1205/155). Ethical approval for version 2.0 of the protocol received on the 19/10/2006. Ethical approval for version 3.0 of the protocol received on the 17/05/2007.

Study design

Prospective multi-centre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic leg ulcer

Intervention

Patients will be randomised to receive 12 weeks therapy with either:
1. PROMOGRAN™ Wound Modulating Matrix
2. PROMOGRAN PRISMA™ Wound Balancing Matrix

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Response to treatment defined as either a more than or equal to 50% wound area reduction from the baseline to the 12 week wound area measurements or complete healing by 12 weeks.

Secondary outcome measures

1. Initial response to treatment at six weeks defined a more than or equal to 50% wound area reduction from the baseline to the six week wound area measurements or complete healing by six weeks
2. Percentage baseline wound area reduction by 12 weeks
3. Safety - Serious Adverse Events

Overall trial start date

01/03/2007

Overall trial end date

30/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over with a venous leg ulcer
2. Duration of ulcer greater than or equal to 30 days
3. Ulcer greater than or equal to 1 cm^2 in area
4. Ankle Brachial Pressure Index (ABPI) greater than or equal to 0.80
5. Written informed consent
6. Able to comply with study treatment and follow-up schedule

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Current exclusion criteria as of 07/07/2008:
1. Participating in another wound related study or intervention trial
2. Clinical signs of an infection of the target ulcer
3. Sharp debridement within past seven days
4. Pre-study (one month) treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy, chemotherapy, vascular or plastic surgery to the affected limb
5. Expected to require treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy or chemotherapy during the study period
6. Planned or expected to require vascular or plastic surgery to the affected limb, during the study period
7. Pre-study use (at any time) of the study dressings (PROMOGRAN™ Matrix and/or PROMOGRAN™ PRISMA Matrix)
8. Pre-study (one month) use of Active Wound Care Therapies
9. Pre-study (one week) use of silver-based products, larval therapy, iodine/povidone-iodine products, enzymatic debriding agents, topical corticosteroids, topical antibiotics, topical antifungal treatments, or antimicrobial agents (cleansing agents/dressings/topical treatments)
10. Known hypersensitivity to any of the dressing components
11. Life expectancy less than six months

Previous exclusion criteria:
1. Participating in another wound related study or intervention trial
2. Diabetes
3. Clinical signs of an infection of the target ulcer
4. Sharp debridement within past seven days
5. Pre-study (one month) treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy, chemotherapy, vascular or plastic surgery to the affected limb
6. Expected to require treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy or chemotherapy during the study period
7. Planned or expected to require vascular or plastic surgery to the affected limb, during the study period
8. Pre-study use (at any time) of the study dressings (PROMOGRAN™ Matrix and/or PROMOGRAN™ PRISMA Matrix)
9. Pre-study (one month) use of Active Wound Care Therapies
10. Pre-study (one week) use of silver-based products, larval therapy, iodine/povidone-iodine products, enzymatic debriding agents, topical corticosteroids, topical antibiotics, topical antifungal treatments, or antimicrobial agents (cleansing agents/dressings/topical treatments)
11. Known hypersensitivity to any of the dressing components
12. Life expectancy less than six months

Recruitment start date

01/03/2007

Recruitment end date

30/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9NG
United Kingdom

Sponsor information

Organisation

Johnson & Johnson Wound Management (UK)

Sponsor details

Johnson and Johnson Medical Ltd
Airebank Mills
Gargrave
Skipton
North Yorkshire
BD23 3RX
United Kingdom

Sponsor type

Industry

Website

http://www.jnjgateway.com/home.jhtml?loc=GBENG&page=viewContent&contentId=09008b98804404e4

Funders

Funder type

Industry

Funder name

Yorkshire Forward (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Johnson & Johnson Wound Management (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes