Diabetic Foot Ulcers
Conditions
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.
Interventions
DEVICEPROMOGRAN
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
DEVICETielle
Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing
Sponsors
Systagenix Wound Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction in wound area and cost effectiveness | 12 weeks | The relative reductions in wound surface area from baseline over twelve weeks of treatment. |
Countries
Germany, Italy, Spain, United Kingdom, United States
Contacts
Primary ContactBreda Cullen, PHD
Outcome results
None listed