Back to results

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

Primary Purpose

Diabetic Foot Ulcers

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

PROMOGRAN

Tielle

About this trial

This is an interventional treatment trial for Diabetic Foot 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 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
Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion

Exclusion Criteria:

Wound duration of less than 6 weeks or longer than 2 years
Known hypersensitivity to any of the wound dressing used in the trial
Current local or systemic antibiotics in the week prior to inclusion
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

Sites / Locations

Penn North Centers for advance wound careRecruiting
Diabetes Klinik Bad Mergentheim Gmbh&CO. KGRecruiting
University of PisaRecruiting
Clinica Universitaria de PodologiaRecruiting
Bradford Royal InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Promogran and High EPA

Promogran and Low EPA

High EPA and standrad of care

Low EPA and standard of care

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reduction in wound area and cost effectiveness

The relative reductions in wound surface area from baseline over twelve weeks of treatment.

Full Information

NCT ID

NCT01537016

First Posted

February 16, 2012

Last Updated

July 4, 2013

Sponsor

Systagenix Wound Management

1. Study Identification

Unique Protocol Identification Number

NCT01537016

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

August 2013 (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

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.

6. Conditions and Keywords

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

Diabetic Foot Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Promogran and High EPA

Arm Type

Experimental

Arm Description

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

Arm Title

Promogran and Low EPA

Arm Type

Experimental

Arm Description

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

Arm Title

High EPA and standrad of care

Arm Type

Active Comparator

Arm Description

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

Arm Title

Low EPA and standard of care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

PROMOGRAN

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Tielle

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Reduction in wound area and cost effectiveness

Description

The relative reductions in wound surface area from baseline over twelve weeks of treatment.

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 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 Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion Exclusion Criteria: Wound duration of less than 6 weeks or longer than 2 years Known hypersensitivity to any of the wound dressing used in the trial Current local or systemic antibiotics in the week prior to inclusion 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

Central Contact Person:

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

Breda Cullen, PHD

Phone

01756747510

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

Dr 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

Diabetes Klinik Bad Mergentheim Gmbh&CO. KG

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karl Zink, MD

Phone

0049 (0)7931594139

zink@diabetes-zentrum.dewww

First Name & Middle Initial & Last Name & Degree

Karl Zink, MD

Facility Name

University of Pisa

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alberto Piaggesi, Prof

Phone

050992436

a.piaggesi@ao-pisa.toscana.it

First Name & Middle Initial & Last Name & Degree

Alberton Piaggesi, MD

Facility Name

Clinica Universitaria de Podologia

City

Madrid

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yolanda Alvarez, MD

Phone

34 (91) 3942203

yolienf3@hotmail.com

First Name & Middle Initial & Last Name & Degree

Jose Luis Martinez, Prof

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs