Clinical trial NCT01537016: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Systagenix Wound Management
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Reduction in wound area and cost effectiveness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Eire
country: United States
facility: Penn North Centers for advance wound care
state: Pennsylvania
city: Bad Mergentheim
country: Germany
facility: Diabetes Klinik Bad Mergentheim Gmbh&CO. KG
city: Pisa
country: Italy
facility: University of Pisa
city: Madrid
country: Spain
facility: Clinica Universitaria de Podologia
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: Yorkshire
Study officials:
affiliation: Cardiff University
name: Keith Harding, Prof
role: PRINCIPAL_INVESTIGATOR
References: