NCT04058197: D-SCOUT

Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment

Withdrawn Phase 1, PHASE2 Last updated 2 December 2021

What this trial tests

Phase 1, PHASE2 trial testing Deferoxamine Product in Chronic Cutaneous Ulcer. Withdrawn.

Timeline

21 July 2020

Primary endpoint
6 October 2021

6 October 2021

Quick facts

Lead sponsor	TauTona Group
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	21 July 2020
Primary completion	6 October 2021
Estimated completion	6 October 2021
Sites	4 locations across United States

Drugs / interventions tested

• Deferoxamine Product — full drug profile →
• Placebo

Conditions studied

• Chronic Cutaneous Ulcer — all drugs for Chronic Cutaneous Ulcer →
• Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

TauTona Group — full company profile →

Who can join

18 and older, any sex, with Chronic Cutaneous Ulcer or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment dilemmas: strategies for priapism, chronic leg ulcer disease, and pulmonary hypertension in sickle cell disease.
   Azbell RCG, Desai PC. · · 2021 · cited 8× · PMID 34889382 · DOI 10.1182/hematology.2021000275
2. Interventions for treating leg ulcers in people with sickle cell disease.
   Martí-Carvajal AJ, Knight-Madden JM, Martinez-Zapata MJ. · · 2021 · cited 3× · PMID 34559425 · DOI 10.1002/14651858.cd008394.pub4