Status:
WITHDRAWN
Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment
Lead Sponsor:
TauTona Group
Conditions:
Chronic Cutaneous Ulcer
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 t...
Detailed Description
Approximately 60 subjects will be enrolled to allow for up to 48 male or female subjects with SCD and cutaneous ulcers to complete this double-blind, placebo-controlled study. A sentinel group of 3 s...
Eligibility Criteria
Inclusion
- Male or female, \>18 years of age
- Diagnosed with Sickle Cell Disease (SS, SC, Sß-thalassemia, SD, SOArab)
- 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.
- Ulcer healed by \< 25% during the SOC run-in period prior to Visit 4 randomization.
- Subject is willing to use acceptable form of birth control (per Section 4.2) during trial and for one month thereafter
Exclusion
- 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.
- The subject has a major uncontrolled medical disorder, such as serious cardiovascular, renal, liver, pulmonary disease, or pulmonary disease (per Investigator discretion).
- Any condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
- Previous participation in another clinical trial within 30 days prior to study entry
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04058197
Start Date
July 21 2020
End Date
October 6 2021
Last Update
December 2 2021
Active Locations (4)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Miami
Miami, Florida, United States, 33136
3
Sonar Clinical Research LLC
Atlanta, Georgia, United States, 30315
4
Montefiore Medical Center
The Bronx, New York, United States, 10467