Diabetic Foot UlcersPhase 1/2NCT02367690
Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients
A Phase 1/2 study testing Selinexor and Standard-of-Care in people with Diabetic Foot Ulcers, run by Karyopharm Therapeutics Inc at 1 site in New Zealand.
Trial summary
Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Selinexor and Standard-of-Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jan 2015to Sep 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a clinical diagnosis of Type I or Type II diabetes mellitus with an HbA1c ≤ 10.0 and has a BMI ≤40.
- The DFU(s) to be treated must be:
- Anatomically discrete,
- Non-healing, but has persisted for ≤12 months
- Measures 1 cm2 ≤ area ≤ 5 cm2 following debridement,
- Has a Wagner Grade 1 (i.e., not involving bone, muscle, tendons, or ligaments),
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- The Target DFU is located distal to the ankle (i.e., below the malleolus), and
- Is able to be adequately off-loaded.
- The patient has adequate arterial blood supply in the affected limb at screening.
- Patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using Semmes-Weinstein 5.07 monofilament at screening.
Who cannot join
- Patient has a foot ulcer that is clearly of non-diabetic pathophysiology.
- Patient has more than two (2) DFUs on the target lower extremity.
- DFU is clinically infected.
- Patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2, Multi-Dose, Evaluator-Blinded, Randomized, Vehicle & Standard Of Care-Controlled Dose-Escalation Study To Assess Safety, Tolerability, Pharmacokinetics Of Topical Selinexor In Patients With Diabetic Foot Ulcers
Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel.
Read the detailed description
Approximately 30 patients who meet the eligibility criteria will be enrolled. Eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure.
After screening, qualified patients will be treated for up to 12 weeks. Patients who achieve complete ulcer closure will be followed for an additional 12 weeks.
All patients will receive standard-of-care treatment. After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. Patients receiving Selinexor will be assigned to a sequential treatment cohort, either a 10 μM (μmol/L), 30 μM, or 70 μM dose.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Selinexor, Standard-of-Care, Vehicle Gel
- Keywords
- Diabetes, Foot Ulcers, DFU, KPT-330, Selinexor, Karyopharm
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called KPT-330
Topical gel
Standard-of-CareOther
Also called SOC
Surgical debridement, sterile saline rinses, and dressing changes.
Vehicle GelOther
Topical vehicle gel with no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will be randomized to one of the following treatment groups:
a) Standard-of-care (SOC) + Selinexor gel, 10 μM
, b) SOC + vehicle gel c) SOC alone. Receives: Drug: Selinexor; Other: Standard-of-Care; Other: Vehicle Gel |
| Cohort 2 | Experimental | Cohort 2 will be randomized to one of the following treatment groups:
1. Standard-of-care (SOC) + Selinexor gel, 30 μM
2. SOC + vehicle gel
3. SOC alone. Receives: Drug: Selinexor; Other: Standard-of-Care; Other: Vehicle Gel |
| Cohort 3 | Experimental | Cohort 3 will be randomized to one of the following treatment groups:
1. Standard-of-care (SOC) + Selinexor gel, 70 μM
2. SOC + vehicle gel
3. SOC alone. Receives: Drug: Selinexor; Other: Standard-of-Care; Other: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Local Skin Reactions (LSR)
Presence of local skin reactions (erythema, edema, pain, tenderness, induration, swelling, wound drainage, purulence, odor, cellulitis, callus, and maceration) within 4 cm of the diabetic foot ulcer wound edge.
Measured: 84 days
Secondary outcomes (1)
Ulcer Closure
Proportion of patients in each treatment group with complete ulcer closure of the target diabetic foot ulcer.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionSep 2015
Why it stopped: Due to enrollment challenges \& improved SOC during run-in phase; no patients received KPT-330. Withdrawal is not a consequence of any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karyopharm Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367690
- Sponsor's protocol ID
- KCP-330-501
- Status last verified
- Jan 2023
- First submitted
- 9 Feb 2015
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Multi-Dose, Evaluator-Blinded, Randomized, Vehicle & Standard Of Care-Controlled Dose-Escalation Study To Assess Safety, Tolerability, Pharmacokinetics Of Topical Selinexor In Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02367690
- Acronym / sponsor ID
- KCP-330-501
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetes, Foot Ulcers, DFU, KPT-330, Selinexor, Karyopharm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to enrollment challenges \& improved SOC during run-in phase; no patients received KPT-330. Withdrawal is not a consequence of any safety concern.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karyopharm Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- 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.
Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel.
Detailed description
Approximately 30 patients who meet the eligibility criteria will be enrolled. Eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure.
After screening, qualified patients will be treated for up to 12 weeks. Patients who achieve complete ulcer closure will be followed for an additional 12 weeks.
All patients will receive standard-of-care treatment. After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. Patients receiving Selinexor will be assigned to a sequential treatment cohort, either a 10 μM (μmol/L), 30 μM, or 70 μM dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Selinexor, Other: Standard-of-Care, Other: Vehicle GelCohort 1 will be randomized to one of the following treatment groups: a) Standard-of-care (SOC) + Selinexor gel, 10 μM , b) SOC + vehicle gel c) SOC alone. |
| Cohort 2 | Experimental | Drug: Selinexor, Other: Standard-of-Care, Other: Vehicle GelCohort 2 will be randomized to one of the following treatment groups: 1. Standard-of-care (SOC) + Selinexor gel, 30 μM 2. SOC + vehicle gel 3. SOC alone. |
| Cohort 3 | Experimental | Drug: Selinexor, Other: Standard-of-Care, Other: Vehicle GelCohort 3 will be randomized to one of the following treatment groups: 1. Standard-of-care (SOC) + Selinexor gel, 70 μM 2. SOC + vehicle gel 3. SOC alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient has a clinical diagnosis of Type I or Type II diabetes mellitus with an HbA1c ≤ 10.0 and has a BMI ≤40.
- The DFU(s) to be treated must be:
- The patient has adequate arterial blood supply in the affected limb at screening.
- Patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using Semmes-Weinstein 5.07 monofilament at screening.
Key exclusion criteria (4 listed)
- Patient has a foot ulcer that is clearly of non-diabetic pathophysiology.
- Patient has more than two (2) DFUs on the target lower extremity.
- DFU is clinically infected.
- Patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease
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 |
|---|---|---|
| SelinexorAlso: KPT-330Topical gel | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Standard-of-CareAlso: SOCSurgical debridement, sterile saline rinses, and dressing changes. | Other | Cohort 1, Cohort 2, Cohort 3 |
| Vehicle GelTopical vehicle gel with no active ingredients. | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Presence of Local Skin Reactions (LSR)
Time frame: 84 days
Presence of local skin reactions (erythema, edema, pain, tenderness, induration, swelling, wound drainage, purulence, odor, cellulitis, callus, and maceration) within 4 cm of the diabetic foot ulcer wound edge.
1 secondary outcome
Ulcer Closure
Time frame: 84 days
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 20 Jan 2023.
- Individual participant dataSharing planned: Yes
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
1 site 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 Selinexor and Standard-of-Care in people with Diabetic Foot Ulcers, run by Karyopharm Therapeutics Inc at 1 site in New Zealand.
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 10 inclusion and 4 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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. 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?
Presence of Local Skin Reactions (LSR) (time frame: 84 days). 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 20 Jan 2023.