A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management o… (NCT01013792) | Clinical Trial Compass
TerminatedNot Applicable
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Stopped: Expired study materials; low subject recruitment
United States30 participantsStarted 2009-11
Plain-language summary
The primary objective is to:
* Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
Secondary objectives are to:
* Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.
* Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.
* Assess and compare the impact that these dressings have on patients' quality of life.
* Assess the wound's biological response and pH to the study dressings.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is the subject 18 years of age or older?
. Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?
. Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
. Does the subject show evidence of neuropathy?
. Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?
. Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit
. Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
. Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
Exclusion criteria
. Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
. Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
. Does the subject have an infection requiring systemic antibiotic treatment?
. Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
. Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)
. Does the subject have Lupus or Crohn's disease?
. Does the subject have an oxygen dependency?
. Has the subject received hyperbaric oxygen therapy within the previous 90 days?