Diabetic Foot UlcerPhase 1/2InTREPiDNCT03654989
Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers
A Phase 1/2 study testing Treprostinil iontophoresis in people with Diabetic Foot Ulcer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU. In the present study the investigators aim at establishing the proof-of-concept of iontophoresis of treprostinil as a potential treatment of diabetic foot ulcers in humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Treprostinil iontophoresis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2020to 7 Dec 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
- Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA), with one or more foot ulcer of microvascular or mixed etiology:
- The ulcer size must be ≥1 cm² and <20 cm²
- Grade 1A, 1C, 2A or 2C (University of Texas Classification of Diabetic Foot)
- Patient affiliated to social security insurance or beneficiary of social security insurance.
Who cannot join
- History of hypersensitivity reaction to treprostinil
- Pulmonary veno-occlusive disease (PVOD)
- Systemic treatment with any PGI2 analogue in the past two months.
- Critical ischemia of the lower limb, defined as leg pain at rest associated with ankle pressure <50 mmHg.
- Infected wound, treated with antibiotics in the past 15 days.
- Active or uncontrolled cardiovascular disease as follows:
Show all 23Show fewer
- Myocardial infarction, or angina within 6 months of study participation
- Arrhythmia (uncontrolled, highly symptomatic, requires treatment or life-threatening).
- Congestive heart failure.
- Stroke or transient ischemic attack within 3 months of study participation
- Uncontrolled hypertension: systolic blood pressure> 180 mmHg or diastolic blood pressure> 105 mmHg (2 abnormal readings during visit)
- Valvular heart disease
- Severe liver disease (Child-Pugh C) at the time of enrollment
- Active gastroduodenal ulcer
- Intracerebral hemorrhage
- Trauma or any clinical event susceptible to be responsible for hemorrhage within 6 months of study participation
- Renal disease (creatinine > 2 mg/dL and/or estimated glomerular filtration rate<30 mL/min, history of dialysis)
- Unstable diabetes that has resulted in hyperosmolar coma or ketoacidosis, and/or documented increase or decrease in HbA1c of more than 2.0% within the previous 3 months.
- Pregnancy or Lactation
- Females of childbearing potential not using an effective form of birth control as determined by the investigators.
- Participant involved in another interventional clinical study
- Person deprived of liberty by judicial order
- Person under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU.
In the present study the investigators aim at establishing the proof-of-concept of iontophoresis of treprostinil as a potential treatment of diabetic foot ulcers in humans. The main hypothesis is that in patients with DFUs, the pharmacodynamic effect of a PGI2 analogue potentiates the effect of low-intensity current on microvascular function, tissue oxygenation and healing.
Read the detailed description
Diabetic foot ulcers (DFUs) represent a serious public health problem associated with significant morbidity and health costs. Despite optimal etiologic treatment and local care, amputation is frequent, stressing the need for new treatments. Tissue ischemia is the primary cause for nonhealing DFUs. The cutaneous microcirculation, by providing tissue perfusion, fluid hemostasis, and delivery of oxygen and nutrients, plays a critical role in the pathophysiology and impaired healing of DFUs.
The investigators therefore hypothesize that the skin microcirculation, and more specifically the prostacyclin (PGI2) pathway, is an interesting target for the local treatment of DFUs. Indeed, besides its potent vasodilator effect, PGI2 plays a role in the promotion of fibroblast migration and angiogenesis in wound models.
However, the benefit of systemic (i.e. IV or SC) treatments is counterbalanced by potentially serious vasodilatation-induced side effects (e.g. severe headaches, flushing, tachycardia and hypotension). These properties are dose-limiting and are associated with safety issues and increased costs. The paradox is that impaired microvasculature prevents the drug, when administered intravenously, from diffusing properly to the wound. Elevated doses are therefore needed, leading to adverse drug reactions.
The originality of this approach is to locally deliver negatively charged PGI2 analogues into and around the wound under the influence of a low-intensity current, through a method called iontophoresis. Iontophoresis enables a controlled delivery of ionized drugs into/through the skin under the influence of low-intensity current. In addition, endogenous electrical signals in the wound are known to play a role in healing, by increasing the directed migration of keratinocytes, fibroblasts and neutrophils. Exogenous electric stimulation would mimic this phenomenon with a positive impact on wound healing. In summary, both the drug and its vehicle could therefore work synergistically, while delivering the drug locally therefore limiting side effects due to systemic diffusion.
This is a prospective, monocentric, controlled, randomized, double-blinded phase I/II study The main objective is to assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU. The investigators will compare wound closure, expressed as the percentage change of the wound area over time (12-week follow-up), between 3 groups: iontophoresis of treprostinil, iontophoresis of placebo, and standard of care. Wound area will be assessed with a digital camera and image analysis software.
Secondary objectives are:
- To assess the effect of iontophoresis of treprostinil on complete healing over 3 months
- To assess the effect of iontophoresis of treprostinil on the time to complete healing
- To assess the effect of iontophoresis of treprostinil on skin perfusion at the site of the ulcer and around the wound
- To evaluate the effect of iontophoresis of treprostinil on skin oxygenation around the lesion and on healed skin
- To assess the pharmacokinetics (PK) of topical administration of treprostinil over damaged (wounded)
- To evaluate the safety of the procedure
The study will be divided into two consecutive parts:
Part 1: 8 to 24 patients with DFU (depending on the total number of doses tested, and the number of doses per patient) will be included in a single ascending dose (SAD) safety study of treprostinil iontophoresis.
Part 2: 36 patients with DFU associated with microvascular dysfunction (+/- neuropathy) will be randomized into three groups to receive either: 1. Treprostinil iontophoresis; 2. Placebo iontophoresis; 3. Standard care. Drug administration (placebo or treprostinil), but not standard care, will be double-blind. After a 10-day treatment, follow-up includes 6 visits over 10 weeks.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Treprostinil iontophoresis, Remodulin® placebo iontophoresis
- Keywords
- Iontophoresis, Treprostinil, Diabetic, Foot Ulcer, Wound Healing
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil iontophoresisDrug
We will administer treprostinil at increasing doses by a iontophoresis.
Remodulin® placebo iontophoresisDevice
Placebo iontophoresis will be performed using Remodulin® placebo (United Therapeutics) delivered with Axion GmbH electrodes connected to a PeriIont generator (Perimed).
- Part 1: 1 administration/day, on separate days, with 72h between two doses. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm².
- Part 2: 1 administration/day for 10 days. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm².
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil iontophoresis | Experimental | Gel of treprostinil 1 mg/mL (target concentration)
* Part 1: 1 administration/day, on separate days, with 72h between two doses. Ascending doses are 0.025 mg/mL, 0.05mg/mL, 0.1 mg/mL, 0.25 mg/mL, 0.5 mg/mL, 0.7 mg/mL, and 1 mg/mL. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm².
* Part 2: 1 administration/day at the maximum tolerated dose (MTD) for 10 days; dressing will be changed by a trained nurse every 2 days. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm². Receives: Drug: Treprostinil iontophoresis |
| Remodulin® Placebo iontophoresis | Placebo comparator | Placebo will be made from the placebo of Remodulin® incorporated into hydrogel (Suprasorb® G). The route and frequency of administration will be the same as for the investigational drug (topical administration by iontophoresis). Receives: Device: Remodulin® placebo iontophoresis |
| Standard care | No intervention | subjects randomized to the standard of care group (no iontophoresis) will only undergo standard blood test at visit 0 or 1, unless tests <1 month before inclusion are available This group is not double blind Standard care consists on debridement and dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of wound closure between the 3 groups: iontophoresis of treprostinil, iontophoresis of placebo, and standard of care, over12 weeks.
Wound closure is expressed as the percentage change non-reepithelialized skin area over time (12-week follow-up), assessed with a digital camera and image analysis software.
Measured: Up to 12 weeks
Secondary outcomes (8)
The percentage of patients with complete healing at the last follow-up visit
Wound area will be assessed with a digital camera and image analysis software.
Measured: week 12
Comparison of time to complete healing between groups
Time to complete reepithelialization will be sought in the medical record on a monthly basis.
Measured: From date of randomization until the date of documented healing, assessed up to 12 months.
The effect of iontophoresis of treprostinil on skin perfusion assessed with laser speckle contrast imaging at the site of the ulcer and around the wound
Cutaneous perfusion will be assessed as cutaneous vascular conductance, and compared between groups
Measured: day 9
Comparison of skin oxygenation around the lesion and on healed skin (when possible)
Comparison using transcutaneous pressure of oxygen
Measured: Day 0 and Day 9 and week 12
8-hour PK profile. AUC0-8
8-hour PK profile. AUC0-8 will be calculated from seven time points: immediately after the end of iontophoresis ( T0), 15 min, 30 min, 1h, 2h, 4h, and 8h
Measured: part 1 : V1 (day0) V2 (day3 or more after V1) V3 (day3 or more after V2) V4 (day3 or more after V3), Part 2 : at days 0 and 9
Incidence of treatment-emergent adverse events, among which hypotension, any cutaneous reaction at the site of iontophoresis, local pain, liver enzymes.
All adverse events will be rated according to the NIH Common Terminology Criteria for Adverse Events.
Measured: During all the study, 3 months of follow-up for every subject
Evaluation of safety via blood pressure
Blood pressure will be continuously recorded with digital photoplethysmography.
Measured: During all the study, 3 months of following for every subject
Evaluation of safety via the appearance of the wound
Photographs of the wound will be taken and sent to investigators, blinded to the group
Measured: During all the study, 3 months of following for every subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start28 Jan 2020
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Model description
- 2 sub-studies: * Preliminary safety study, Phase I: single ascending dose study that aims at establishing the safety, tolerability, and PK of the procedure in patients with active ulcers; we propose an accelerated titration design with 7 doses of gel. The accelerated phase (first four doses) uses single-patient cohorts per dose. After these doses, a standard 3+3 design will be performed. Any occurrence of dose-limiting toxicity (DLT) during the accelerated phase halts the accelerated titration and the cohort is expended to the standard 3+3 design. Two instances of DLT at a dose level halt escalation, and D-1 is the maximum tolerated dose. * Proof-of-concept study, Phase II: Thirty-six patients with DFU associated with microvascular dysfunction will be randomized into three groups: Treprostinil iontophoresis; Placebo iontophoresis; Standard care. Drug administration, but not standard care, will be double-blind. After a 10-day treatment, follow-up includes 6 visits over 10 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cracowski Jean-luc, Professor, Principal investigator, Clinical pharmacology unit, grenoble alpes university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654989
- Sponsor's protocol ID
- 38RC17.163
- Acronym
- InTREPiD
- Status last verified
- Dec 2023
- First submitted
- 20 Aug 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers
- ClinicalTrials.gov ID
- NCT03654989
- Acronym / sponsor ID
- InTREPiD / 38RC17.163
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Iontophoresis, Treprostinil, Diabetic, Foot Ulcer, Wound Healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 31 Aug 2018 (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.
Assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU.
In the present study the investigators aim at establishing the proof-of-concept of iontophoresis of treprostinil as a potential treatment of diabetic foot ulcers in humans. The main hypothesis is that in patients with DFUs, the pharmacodynamic effect of a PGI2 analogue potentiates the effect of low-intensity current on microvascular function, tissue oxygenation and healing.
Detailed description
Diabetic foot ulcers (DFUs) represent a serious public health problem associated with significant morbidity and health costs. Despite optimal etiologic treatment and local care, amputation is frequent, stressing the need for new treatments. Tissue ischemia is the primary cause for nonhealing DFUs. The cutaneous microcirculation, by providing tissue perfusion, fluid hemostasis, and delivery of oxygen and nutrients, plays a critical role in the pathophysiology and impaired healing of DFUs.
The investigators therefore hypothesize that the skin microcirculation, and more specifically the prostacyclin (PGI2) pathway, is an interesting target for the local treatment of DFUs. Indeed, besides its potent vasodilator effect, PGI2 plays a role in the promotion of fibroblast migration and angiogenesis in wound models.
However, the benefit of systemic (i.e. IV or SC) treatments is counterbalanced by potentially serious vasodilatation-induced side effects (e.g. severe headaches, flushing, tachycardia and hypotension). These properties are dose-limiting and are associated with safety issues and increased costs. The paradox is that impaired microvasculature prevents the drug, when administered intravenously, from diffusing properly to the wound. Elevated doses are therefore needed, leading to adverse drug reactions.
The originality of this approach is to locally deliver negatively charged PGI2 analogues into and around the wound under the influence of a low-intensity current, through a method called iontophoresis. Iontophoresis enables a controlled delivery of ionized drugs into/through the skin under the influence of low-intensity current. In addition, endogenous electrical signals in the wound are known to play a role in healing, by increasing the directed migration of keratinocytes, fibroblasts and neutrophils. Exogenous electric stimulation would mimic this phenomenon with a positive impact on wound healing. In summary, both the drug and its vehicle could therefore work synergistically, while delivering the drug locally therefore limiting side effects due to systemic diffusion.
This is a prospective, monocentric, controlled, randomized, double-blinded phase I/II study The main objective is to assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU. The investigators will compare wound closure, expressed as the percentage change of the wound area over time (12-week follow-up), between 3 groups: iontophoresis of treprostinil, iontophoresis of placebo, and standard of care. Wound area will be assessed with a digital camera and image analysis software.
Secondary objectives are:
- To assess the effect of iontophoresis of treprostinil on complete healing over 3 months
- To assess the effect of iontophoresis of treprostinil on the time to complete healing
- To assess the effect of iontophoresis of treprostinil on skin perfusion at the site of the ulcer and around the wound
- To evaluate the effect of iontophoresis of treprostinil on skin oxygenation around the lesion and on healed skin
- To assess the pharmacokinetics (PK) of topical administration of treprostinil over damaged (wounded)
- To evaluate the safety of the procedure
The study will be divided into two consecutive parts:
Part 1: 8 to 24 patients with DFU (depending on the total number of doses tested, and the number of doses per patient) will be included in a single ascending dose (SAD) safety study of treprostinil iontophoresis.
Part 2: 36 patients with DFU associated with microvascular dysfunction (+/- neuropathy) will be randomized into three groups to receive either: 1. Treprostinil iontophoresis; 2. Placebo iontophoresis; 3. Standard care. Drug administration (placebo or treprostinil), but not standard care, will be double-blind. After a 10-day treatment, follow-up includes 6 visits over 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 2 sub-studies: * Preliminary safety study, Phase I: single ascending dose study that aims at establishing the safety, tolerability, and PK of the procedure in patients with active ulcers; we propose an accelerated titration design with 7 doses of gel. The accelerated phase (first four doses) uses single-patient cohorts per dose. After these doses, a standard 3+3 design will be performed. Any occurrence of dose-limiting toxicity (DLT) during the accelerated phase halts the accelerated titration and the cohort is expended to the standard 3+3 design. Two instances of DLT at a dose level halt escalation, and D-1 is the maximum tolerated dose. * Proof-of-concept study, Phase II: Thirty-six patients with DFU associated with microvascular dysfunction will be randomized into three groups: Treprostinil iontophoresis; Placebo iontophoresis; Standard care. Drug administration, but not standard care, will be double-blind. After a 10-day treatment, follow-up includes 6 visits over 10 weeks.
| Arm | Type | Receives |
|---|---|---|
| Treprostinil iontophoresis | Experimental | Drug: Treprostinil iontophoresisGel of treprostinil 1 mg/mL (target concentration) * Part 1: 1 administration/day, on separate days, with 72h between two doses. Ascending doses are 0.025 mg/mL, 0.05mg/mL, 0.1 mg/mL, 0.25 mg/mL, 0.5 mg/mL, 0.7 mg/mL, and 1 mg/mL. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm². * Part 2: 1 administration/day at the maximum tolerated dose (MTD) for 10 days; dressing will be changed by a trained nurse every 2 days. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm². |
| Remodulin® Placebo iontophoresis | Placebo comparator | Device: Remodulin® placebo iontophoresisPlacebo will be made from the placebo of Remodulin® incorporated into hydrogel (Suprasorb® G). The route and frequency of administration will be the same as for the investigational drug (topical administration by iontophoresis). |
| Standard care | No intervention | –subjects randomized to the standard of care group (no iontophoresis) will only undergo standard blood test at visit 0 or 1, unless tests <1 month before inclusion are available This group is not double blind Standard care consists on debridement and dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA), with one or more foot ulcer of microvascular or mixed etiology:
- Patient affiliated to social security insurance or beneficiary of social security insurance.
Key exclusion criteria (23 listed)
- History of hypersensitivity reaction to treprostinil
- Pulmonary veno-occlusive disease (PVOD)
- Systemic treatment with any PGI2 analogue in the past two months.
- Critical ischemia of the lower limb, defined as leg pain at rest associated with ankle pressure <50 mmHg.
- Infected wound, treated with antibiotics in the past 15 days.
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 |
|---|---|---|
| Treprostinil iontophoresisWe will administer treprostinil at increasing doses by a iontophoresis. | Drug | Treprostinil iontophoresis |
| Remodulin® placebo iontophoresisPlacebo iontophoresis will be performed using Remodulin® placebo (United Therapeutics) delivered with Axion GmbH electrodes connected to a PeriIont generator (Perimed). * Part 1: 1 administration/day, on separate days, with 72h between two doses. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm². * Part 2: 1 administration/day for 10 days. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm². | Device | Remodulin® Placebo iontophoresis |
Primary outcome
Comparison of wound closure between the 3 groups: iontophoresis of treprostinil, iontophoresis of placebo, and standard of care, over12 weeks.
Time frame: Up to 12 weeks
Wound closure is expressed as the percentage change non-reepithelialized skin area over time (12-week follow-up), assessed with a digital camera and image analysis software.
8 secondary outcomes
The percentage of patients with complete healing at the last follow-up visit
Time frame: week 12
Comparison of time to complete healing between groups
Time frame: From date of randomization until the date of documented healing, assessed up to 12 months.
The effect of iontophoresis of treprostinil on skin perfusion assessed with laser speckle contrast imaging at the site of the ulcer and around the wound
Time frame: day 9
Comparison of skin oxygenation around the lesion and on healed skin (when possible)
Time frame: Day 0 and Day 9 and week 12
8-hour PK profile. AUC0-8
Time frame: part 1 : V1 (day0) V2 (day3 or more after V1) V3 (day3 or more after V2) V4 (day3 or more after V3), Part 2 : at days 0 and 9
Incidence of treatment-emergent adverse events, among which hypotension, any cutaneous reaction at the site of iontophoresis, local pain, liver enzymes.
Time frame: During all the study, 3 months of follow-up for every subject
Evaluation of safety via blood pressure
Time frame: During all the study, 3 months of following for every subject
Evaluation of safety via the appearance of the wound
Time frame: During all the study, 3 months of following for every subject
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Cracowski Jean-luc, Professor principal investigator
Clinical pharmacology unit, grenoble alpes university hospital
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 Treprostinil iontophoresis in people with Diabetic Foot Ulcer, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 23 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: stopped early, as of the sponsor's last update on 12 Dec 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 France. 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 stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Comparison of wound closure between the 3 groups: iontophoresis of treprostinil, iontophoresis of placebo, and standard of care, over12 weeks. (time frame: Up to 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 12 Dec 2023.