Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment (NCT04058197) | Clinical Trial Compass
WithdrawnPhase 1/2
Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment
Stopped: Lack of enrollment
United States0Started 2020-07-21
Plain-language summary
Approximately 60 subjects will be enrolled into this double-blind, placebo-controlled study for the Deferoxamine Intradermal Delivery Patch (DIDP).
Those subjects who pass Screening will enter into the 2-week Standard of Care (SOC) Run-In period. During this time, ulcers will be assessed to check healing based on digital planimetry, and qualitative features of the ulcer. Subjects who meet eligibility criteria at the end of the 2-week Run-in Period will be randomized into active and control groups (2 active to 1 placebo) and enter the 12-week Treatment Period. At each visit during the Treatment Period, the target ulcer will be measured by digital photographic planimetry, the Principal Investigator will assess the wound qualitative attributes, and the DIDP (or placebo patch) will be placed as the primary wound dressing. At each visit the subject will also receive/review a daily diary to document pain , study drug compliance, and analgesic use.
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.
. Cutaneous ulcer with a University of Texas Wound Classification System Grade 1A or 2A (= Wagner class 1or 2, without infection or ischemia)
. Ulcer on lower leg, ankle, or dorsum of foot
. Vascular status of site assessed and judged adequate for healing (per Section 4.2)
. Ulcer present ≥ 14 days but not \> 6 months at time of screening
. Ulcer 2.0 cm2 to 45.0 cm2 and \< 6.0 cm diameter at widest point after debridement, prior to randomization.
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
Incidence of Treatment-Emergent Adverse Events [Safety / Tolerability]
. Ulcer healed by \< 25% during the SOC run-in period prior to Visit 4 randomization.
Exclusion criteria
. Active infection/purulence at ulcer site, based on Investigator's clinical judgement
. Current or history of osteomyelitis at or near site of ulcer
. Serum albumin \< 2.0 g/dL
. Treatment with systemic DFO within 7 days of study entry
. Serum ferritin \> 1000 ng/mL
. Subjects requiring, or expected to require, iron chelation therapy (systemic deferoxamine, deferasirox, or deferiprone) during the duration of the study.
. Subjects on dialysis or with evidence of nephrotic syndrome.
. Known bleeding or coagulation disorder that would preclude surgical debridement, as necessary.