Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone (NCT06455475) | Clinical Trial Compass
TerminatedNot Applicable
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Stopped: Discontinued after an Interim Analysis
United States120 participantsStarted 2024-10-25
Plain-language summary
This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers
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
. Subjects18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
. Subjects with the following ulcer:
. Objectively, less than 20% healing in the two-week screening period prior to randomization.
. Study ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
. Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
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
Wound Closure Assessment Verified with Independent Adjudication
. The subject is able and willing to follow the protocol requirements.
. Subject has signed informed consent.
Exclusion criteria
. Subject has a known life expectancy of \< 1 year.
. Index ulcer has been present for \>1 year.
. Patient does not have adequate 2-week historical data demonstrating \< 20% area reduction.
. Subject is unable to comply with offloading device.
. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
. Subject has ulcers that are completely necrotic or fibrotic tissue
. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.