Chronic Cutaneous UlcerPhase 1/2D-SCOUTNCT04058197
Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment
A Phase 1/2 study testing Deferoxamine Product in people with Chronic Cutaneous Ulcer and Sickle Cell Disease, run by TauTona Group at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cutaneous Ulcer, Sickle Cell Disease
- What is being tested?
- Deferoxamine Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jul 2020to 6 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sonar Clinical Research LLC
Atlanta, Georgia, 30315
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Miami
Miami, Florida, 33136
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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
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.
Read the 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 subjects will be enrolled and evaluated for safety (while still blinded). The remaining subjects will be enrolled in a 2:1 ratio, active:placebo.
Those subjects who pass Screening will enter into the 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 Run-in Period will be randomized and enter the 12-week Treatment Period.
The DIDP (or placebo) will be replaced daily at home. The subject will visit the clinic on an approximately weekly basis for study assessments, to include imaging and planimetric wound measurements and qualitative wound assessments. Clinical laboratory samples will be collected at Treatment Baseline, Treatment Weeks 4, 8 and 12, or at End of Study (EOS) visit if sooner. A blood sample for PK testing will also be collected at these timepoints. During this Treatment Period, if at any time the wound has met the criterion for 100% healing, the subject will immediately go into the 4-week Follow-up Period.
During the Follow-up Period, the subject will come to the clinic at 1-week intervals. At these visits, the area of the wound will continue to be protected with a protective dressing. Clinical laboratory samples will be collected at the Termination Visit.
Ulcer pain will be assessed by the subject daily and recorded in a diary, along with a record of analgesic use. At each visit, study staff will assist the subjects to assign an overall ulcer pain score for the week.
Quality of Life Assessment will be performed at Baseline prior to dosing and at End of Treatment.
Safety will be assessed based upon known adverse outcomes of Deferoxamine (DFO) therapy. Skin will be examined for evidence of rash and skin irritation.
- Conditions
- Chronic Cutaneous Ulcer, Sickle Cell Disease
- Being tested
- Deferoxamine Product, Placebo
- Keywords
- chronic sickle cell leg ulcer
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferoxamine ProductDrug
Deferoxamine Intradermal Delivery Patch
PlaceboOther
Placebo Patch
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Deferoxamine (DFO) Intradermal Delivery Patch (DIDP), 45mg DFO daily, up to 12 weeks Receives: Drug: Deferoxamine Product |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety / Tolerability]
Incidence of systemic and local adverse events of DIDP applied to non-healing cutaneous leg ulcers. Changes from baseline characteristics that are treatment-related as measured by physical examinations, clinical laboratory, skin and other physiologic assessments.
Measured: 12 weeks
Secondary outcomes (5)
Degree of Wound closure
Percentage of wound closure
Measured: 12 weeks
Partial wound closure incidence
Incidence of 80% closure
Measured: 12 weeks
Total wound closure incidence
Incidence of 100% closure
Measured: 12 weeks
Wound closure rate
rate of closure
Measured: 12 weeks
Ulcer recurrence
Incidence
Measured: 4 week follow-up post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start21 Jul 2020
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cutaneous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauTona Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058197
- Sponsor's protocol ID
- CD1001
- Acronym
- D-SCOUT
- Status last verified
- Nov 2020
- First submitted
- 18 Jun 2019
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04058197
- Acronym / sponsor ID
- D-SCOUT / CD1001
- Conditions
- Chronic Cutaneous Ulcer, Sickle Cell Disease
- Keywords
- chronic sickle cell leg ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TauTona GroupIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 subjects will be enrolled and evaluated for safety (while still blinded). The remaining subjects will be enrolled in a 2:1 ratio, active:placebo.
Those subjects who pass Screening will enter into the 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 Run-in Period will be randomized and enter the 12-week Treatment Period.
The DIDP (or placebo) will be replaced daily at home. The subject will visit the clinic on an approximately weekly basis for study assessments, to include imaging and planimetric wound measurements and qualitative wound assessments. Clinical laboratory samples will be collected at Treatment Baseline, Treatment Weeks 4, 8 and 12, or at End of Study (EOS) visit if sooner. A blood sample for PK testing will also be collected at these timepoints. During this Treatment Period, if at any time the wound has met the criterion for 100% healing, the subject will immediately go into the 4-week Follow-up Period.
During the Follow-up Period, the subject will come to the clinic at 1-week intervals. At these visits, the area of the wound will continue to be protected with a protective dressing. Clinical laboratory samples will be collected at the Termination Visit.
Ulcer pain will be assessed by the subject daily and recorded in a diary, along with a record of analgesic use. At each visit, study staff will assist the subjects to assign an overall ulcer pain score for the week.
Quality of Life Assessment will be performed at Baseline prior to dosing and at End of Treatment.
Safety will be assessed based upon known adverse outcomes of Deferoxamine (DFO) therapy. Skin will be examined for evidence of rash and skin irritation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Deferoxamine ProductDeferoxamine (DFO) Intradermal Delivery Patch (DIDP), 45mg DFO daily, up to 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferoxamine ProductDeferoxamine Intradermal Delivery Patch | Drug | Active |
| PlaceboPlacebo Patch | Other | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety / Tolerability]
Time frame: 12 weeks
Incidence of systemic and local adverse events of DIDP applied to non-healing cutaneous leg ulcers. Changes from baseline characteristics that are treatment-related as measured by physical examinations, clinical laboratory, skin and other physiologic assessments.
5 secondary outcomes
Degree of Wound closure
Time frame: 12 weeks
Partial wound closure incidence
Time frame: 12 weeks
Total wound closure incidence
Time frame: 12 weeks
Wound closure rate
Time frame: 12 weeks
Ulcer recurrence
Time frame: 4 week follow-up post
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deferoxamine Product in people with Chronic Cutaneous Ulcer and Sickle Cell Disease, run by TauTona Group at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety / Tolerability] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.