October, 10 2019

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of Deferoxamine Intradermal Delivery Patch (DIDP) in Chronic Sickle Cell Leg Ulcers

Age

> 18 Years

Phase

Phase 1/Phase 2

About the study

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.

Study Type

Interventional

Phase

Phase 1/Phase 2

Age

> 18 Years

Gender

All

Inclusion Criteria

1. Male or female, >18 years of age

2. Diagnosed with Sickle Cell Disease (SS, SC, Sß-thalassemia, SD, SOArab)

3. Cutaneous ulcer with a University of Texas Wound Classification System Grade 1A or 2A
(= Wagner class 1or 2, without infection or ischemia)

4. Ulcer on lower leg, ankle, or dorsum of foot

5. Vascular status of site assessed and judged adequate for healing (per Section 4.2)

6. Ulcer present ≥ 14 days but not > 6 months at time of screening

7. Ulcer 2.0 cm2 to 45.0 cm2 and < 6.0 cm diameter at widest point after debridement, prior to randomization. 8. Ulcer healed by < 25% during the SOC run-in period prior to Visit 4 randomization. 9. Subject is willing to use acceptable form of birth control (per Section 4.2) during trial and for one month thereafter

Exclusion Criteria

1. Active infection/purulence at ulcer site, based on Investigator’s clinical judgement

2. Current or history of osteomyelitis at or near site of ulcer

3. Serum albumin < 2.0 g/dL 4. Treatment with systemic DFO within 7 days of study entry 5. Serum ferritin > 1000 ng/mL

6. Subjects requiring, or expected to require, iron chelation therapy (systemic
deferoxamine, deferasirox, or deferiprone) during the duration of the study.

7. Subjects on dialysis or with evidence of nephrotic syndrome.

8. Known bleeding or coagulation disorder that would preclude surgical debridement, as
necessary.

9. The subject has a major uncontrolled medical disorder, such as serious cardiovascular,
renal, liver, pulmonary disease, or pulmonary disease (per Investigator discretion).

10. Any condition that in the Investigator’s opinion would warrant exclusion from the
study or prevent the subject from completing the study

11. Previous participation in another clinical trial within 30 days prior to study entry

Interventions

  • Drug
  • Other

Outcome measures

  • Incidence of Treatment-Emergent Adverse Events [Safety / Tolerability]

Contact Research Team

  • Richard Erwin, BS
    650-503-8221
  • Kenneth Krantz, MD, PhD
    650-503-8219

More info

View on ClinicalTrials
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