WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2013 |
| End Date: | August 2013 |
| Contact: | Breda Cullen, PHD |
| Email: | breda.cullen@systagenix.com |
| Phone: | 01756747510 |
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Diabetic Foot Ulcers
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.
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.
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
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