Diabetes Mellitus, Type 2PGI2HEALNCT05099367
Prostacyclin (PGI2) Pathway to Enhance Wound Healing in Diabetic Foot Ulcers
A study testing Microdialysis, current induced vasodilation, Skin biopsy and peri-ulcerated skin biopsy in people with Diabetes Mellitus, Type 2 and Diabetic Foot, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives, samples from a fourth group will be collected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Foot
- What is being tested?
- Microdialysis, current induced vasodilation, Skin biopsy and peri-ulcerated skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 31 Aug 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Groups 1,2,3,4:
- Informed consent signed
- Affiliated to social security insurance or beneficiary of social security insurance
- Aged of 18 or older
- Group 1: healthy volunteers:
- -Free from all acute and chronic pathology
Show all 12Show fewer
- Group 2: diabetic patients without DFU:
- -Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA), without DFU or history of DFU
- Group 3: diabetic patients with DFU or recent history of DFU (occurred within the last two years):
- -Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA) with: One or more active grade 1A, 1C, 2A or 2C (University of Texas Classification of Diabetic Foot) foot ulcer of microvascular or mixed etiology; Or a recent history (<2 years) of foot ulcer of microvascular or mixed etiology.
- Group 4 (to collect samples of foot skin biopsies to address secondary objectives ):
- -Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA),with neuropathy and DFU undergoing lower-limb surgery for skin ulcer (e.g. toe amputation).
Who cannot join
- Groups 1, 2 and 3:
- 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.
- Presence of diabetic peripheral neuropathy above the ankle, defined as a scoring >3 of at least two of the four stimuli of the Neuropathy Disability Score (i.e. pinprick sensation, light touch, vibration, and temperature perception) (37).
- Infected wound, treated with antibiotics in the past 15 days.
- Critical ischemia of the lower limb, defined as leg pain at rest associated with ankle pressure <70 mmHg.
- History of hypersensitivity reaction to treprostinil, fluconazole, other azole compounds, L-NMMA, ketorolac, meloxicam, or any NSAIDs or acetylsalicylic acid, lidocaine (or any local anesthetic with an amide bond), or their excipients
Show all 27Show fewer
- History of asthma, rhinitis, nasal polyps, angioedema, hives rash, or any other allergic reaction due to acetylsalicylic acid or any NSAID taking
- Pulmonary veno-occlusive disease (PVOD)
- Porphyria
- Hyperkalemia
- Active or uncontrolled cardiovascular disease as follows: Myocardial infarction, or angina within the previous 6 months; Severe ischemic heart disease; Arrhythmia (uncontrolled, symptomatic, requiring treatment or life-threatening); Congestive heart failure, or decompensated heart failure not medically controlled; Stroke or transient ischemic attack within the previous 3 months; Uncontrolled hypertension: systolic blood pressure (SBP)> 180 mmHg or diastolic blood pressure (DBP)> 105 mmHg (2 abnormal readings during visit) Valvular heart disease
- Severe liver disease (Child-Pugh C) at the time of enrollment
- Renal disease (creatinine >2 mg/dL and/or estimated glomerular filtration rate (GFR) <30 mL/min, history of dialysis)
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding or perforation with NSAIDs
- Intracerebral or gastrointestinal hemorrhage, hemostasis disorder or every clinical status that may lead to bleeding
- Chronic venous disease defined as stage 4a and 4b of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification
- Cutaneous condition deemed incompatible with skin biopsy and dermal microdialysis by the investigator
- History of necrotic angiodermatitis
- Trauma or any clinical event susceptible to be responsible for hemorrhage within the previous 6 months
- Concomitant treatment with pentoxifylline, anticoagulants, probenecid, medicinal products known to prolong the QT interval or anti-inflammatory or analgesic dose of acetylsalicylic acid
- If concomitant treatment with NSAIDs, participants have to be stopped 1 week before the inclusion
- Pregnancy or Lactation
- Females with childbearing potential, defined as a premenopausal female capable of becoming pregnant, and not using an highly effective form of birth control. Effective birth control methods include: oral, implant or patch hormone contraception; intrauterine device; abstinence and outercourse; tubal ligation; vasectomy.
- Groups 1,2,3 and 4:
- 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.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes Centre d'investigation clinique
Grenoble, 38000
Roustit, mroustit@chu-grenoble.fr
paris, aparis@chu-grenoble.fr
About this study
Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives, samples from a fourth group will be collected.
Read the detailed description
Diabetic foot ulcers (DFUs) are a common and serious complication of diabetes mellitus, and associated with major morbidity. Indeed, diabetes is the primary cause of non-traumatic lower-limb amputation, and the rise in the prevalence of type 2 diabetes worldwide increases the global burden of DFUs. The treatment of DFUs is particularly challenging. Besides etiologic measures, local therapy of foot ulcers mainly relies on debridement of the wound and dressings. Essential complementary measures include pressure off-loading and infection control. However, despite these treatments, complications are frequent, stressing the need for new treatments.
The microcirculation has a key role in tissue survival, and several classical pathways explain how hyperglycemia damages the microvessels. There is growing evidence that the PGI2 pathway is dysregulated in diabetes, which contributes to microvascular dysfunction. Besides its vasodilator effect, recent data has revealed the major role of PGI2 in angiogenesis. In the skin, such effect on healing might be enhanced by the role of PGI2 in the regulation of fibroblast and keratinocytes migration and proliferation.
In the past few decades, studies in diabetic patients with ulcers have shown numerous structural and functional abnormalities of the cutaneous microcirculation, supporting its critical role in the pathophysiology of DFUs. However, the detailed mechanisms underlying endothelial dysfunction in the skin of diabetic patients remain largely unexplored in vivo. A better understanding of the specificities of microvascular changes in the diabetic foot is essential to developing new treatments for this pressing clinical need.
Objectives are
- to explore the role of the PGI2 pathway in skin microvascular reactivity, in healthy subjects and in diabetic patients with and without DFU
- To determine the involvement of COX-1 and COX-2 in cutaneous current-induced vasodilation (CIV), in healthy subjects and in diabetic patients with and without DFU.
- To determine the involvement of sensory nerves in cutaneous CIV, in healthy subjects and in diabetic patients with and without DFU.
- To compare the function of the IP receptor between healthy subjects and diabetic patients with and without DFU.
- To determine the involvement of the nitric oxide (NO) and epoxyeicosatrienoic acids (EETs) pathway in cutaneous CIV, in healthy subjects and in diabetic patients with and without DFU.
- To assess cutaneous expression of the different components of the PGI2 pathway in the skin of healthy subjects and of diabetic patients with and without DFU.
- To assess the role of the PGI2 pathway on cell migration in vitro
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Foot
- Being tested
- Microdialysis, current induced vasodilation, Skin biopsy, peri-ulcerated skin biopsy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdialysis, current induced vasodilationDiagnostic test
CIV will be applied over all microdialysis fibers: one perfused with saline, one perfused with a preferential COX-1 blocker; and one perfused with a preferential COX-2 blocker.
CIV will be applied over all fibers in the following conditions: one perfused with saline, one perfused with fluconazole and L-NMMA, and the last one perfused with lidocaine.Dialysate collection will be performed after each CIV: dermal PGI2 metabolite (6-ketoPGF1α) and other COX-dependent prostanoids or metabolite (e.g. 11-dehydroTXB2) will be collected in the dialysate fluid and quantified. One hour after the last condition, treprostinil will be perfused over all fibers.
Skin biopsyDiagnostic test
Skin biopsy will be proposed. It will be performed on the internal superior calf (medial gastrocnemius), at a reasonable distance from the foot
peri-ulcerated skin biopsyDiagnostic test
Non-ulcerated skin from the peri-wound area will be collected. These patient will not undergo all the procedures included in this protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : healthy subject | Other | 15 healthy subject without diabetes Receives: Diagnostic Test: Microdialysis, current induced vasodilation; Diagnostic Test: Skin biopsy |
| Group 2 : diabetes without ulcer | Other | 15 patients with diabetes type II and without foot ulcer Receives: Diagnostic Test: Microdialysis, current induced vasodilation; Diagnostic Test: Skin biopsy |
| Group 3 : diabetes with ulcer active or <2 years | Other | 15 patients with diabetes type II and with foot ulcer (active or <2years) Receives: Diagnostic Test: Microdialysis, current induced vasodilation; Diagnostic Test: Skin biopsy |
| Group 4 : Patients with type 2 diabetes, neuropathy and DFU undergoing lower limb | Other | Patients with type 2 diabetes and neuropathy and DFU undergoing lower lunb surgery for skin ulcer Receives: Diagnostic Test: peri-ulcerated skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring PGI2 pathway in skin microvascular reactivity
Comparison of skin perfusion measured with laser speckle contrast imaging (LSCI) on the calf, and expressed as arbitrary perfusion units, in response to local cathodal current application, between the three groups
Measured: Day 1
Secondary outcomes (9)
Involvement of COX-1 and 2 in cutaneous current-induced vasodilation
- Comparison of skin perfusion measured with LSCI on the calf, in response to local current application, during local infusion of ketorolac (COX-1 blocker), and meloxicam (COX-2 blocker), using skin microdialysis, between the three groups.
Measured: Day 1
Involvement of sensory nerves in cutaneous current-induced vasodilation
- Comparison of skin perfusion measured with LSCI on the calf, in response to local current application, after local infusion of lidocaine, between the three groups.
Measured: Day 1
IP receptor function
- Comparison of skin perfusion measured with LSCI on the calf, in response to intradermal infusion of treprostinil using skin microdialysis, between the three groups.
Measured: Day 1
Involvement of NO et EETs pathways in cutaneous current-induced vasodilation
- Comparison of skin perfusion measured with LSCI on the calf, in response to local current application, during local infusion of NG-Monomethyl-L-arginine (L-NMMA) and fluconazole using skin microdialysis, between the three groups.
Measured: Day 1
Expression of different components of PGI2 pathway in the skin : PTGS1/2
- Comparison of the expression of Prostaglandin-Endoperoxide Synthase (PTGS1/2 (COX1/2)), in the skin of the calf, between the three groups and a fourth group of foot skin biopsies from patients with diabetes, neuropathy and DFU undergoing lower-limb surgery.
Measured: Day 1
Expression of different components of PGI2 pathway in the skin : PTGIS
- Comparison of the expression of PTGIS (CYP8A1) in the skin of the calf, between the three groups and a fourth group of foot skin biopsies from patients with diabetes, neuropathy and DFU undergoing lower-limb surgery.
Measured: Day 1
Expression of different components of PGI2 pathway in the skin : PTGIR
- Comparison of the expression of PTGIR (IP-receptor) in the skin of the calf, between the three groups and a fourth group of foot skin biopsies from patients with diabetes, neuropathy and DFU undergoing lower-limb surgery.
Measured: Day 1
Expression of different components of PGI2 pathway in the skin : TBXA2R
- Comparison of the expression of TXA2R (TP-receptor) in the skin of the calf, between the three groups and a fourth group of foot skin biopsies from patients with diabetes, neuropathy and DFU undergoing lower-limb surgery.
Measured: Day 1
role of PGI2 pathway on cell migration in vitro
- Cell migration observed on wounded 3D skin equivalents made from cells collected from the three groups and from a fourth group of patients undergoing lower-limb surgery. Fibroblasts and kératinocytes migration on 3D reconstructed skin models.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Oct 2021
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives , samples from a fourth group (patients with diabetes, neuropathy and DFU undergoing lower-limb amputation) will be collected.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099367
- Sponsor's protocol ID
- 38RC18.314
- Acronym
- PGI2HEAL
- Status last verified
- Dec 2023
- First submitted
- 4 Oct 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data sending an e-mail to : jlcracowski@chu-grenoble.fr or mroustit@chu-grenoble.fr
Publications
Knebel SM, Sprague RS, Stephenson AH. Prostacyclin receptor expression on platelets of humans with type 2 diabetes is inversely correlated with hemoglobin A1c levels. Prostaglandins Other Lipid Mediat. 2015 Jan-Mar;116-117:131-5. doi: 10.1016/j.prostaglandins.2014.12.002. Epub 2015 Jan 21.
PubMed 25617843Gohin S, Sigaudo-Roussel D, Conjard-Duplany A, Dubourg L, Saumet JL, Fromy B. What can current stimulation tell us about the vascular function of endogenous prostacyclin in healthy rat skin in vivo? J Invest Dermatol. 2011 Jan;131(1):237-44. doi: 10.1038/jid.2010.267. Epub 2010 Sep 9.
PubMed 20827283Gibbons CH, Freeman R, Veves A. Diabetic neuropathy: a cross-sectional study of the relationships among tests of neurophysiology. Diabetes Care. 2010 Dec;33(12):2629-34. doi: 10.2337/dc10-0763. Epub 2010 Aug 30.
PubMed 20805259Hellmann M, Roustit M, Gaillard-Bigot F, Cracowski JL. Cutaneous iontophoresis of treprostinil, a prostacyclin analog, increases microvascular blood flux in diabetic malleolus area. Eur J Pharmacol. 2015 Jul 5;758:123-8. doi: 10.1016/j.ejphar.2015.03.066. Epub 2015 Apr 3.
PubMed 25843412
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostacyclin (PGI2) Pathway to Enhance Wound Healing in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05099367
- Acronym / sponsor ID
- PGI2HEAL / 38RC18.314
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 29 Oct 2021 (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.
Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives, samples from a fourth group will be collected.
Detailed description
Diabetic foot ulcers (DFUs) are a common and serious complication of diabetes mellitus, and associated with major morbidity. Indeed, diabetes is the primary cause of non-traumatic lower-limb amputation, and the rise in the prevalence of type 2 diabetes worldwide increases the global burden of DFUs. The treatment of DFUs is particularly challenging. Besides etiologic measures, local therapy of foot ulcers mainly relies on debridement of the wound and dressings. Essential complementary measures include pressure off-loading and infection control. However, despite these treatments, complications are frequent, stressing the need for new treatments.
The microcirculation has a key role in tissue survival, and several classical pathways explain how hyperglycemia damages the microvessels. There is growing evidence that the PGI2 pathway is dysregulated in diabetes, which contributes to microvascular dysfunction. Besides its vasodilator effect, recent data has revealed the major role of PGI2 in angiogenesis. In the skin, such effect on healing might be enhanced by the role of PGI2 in the regulation of fibroblast and keratinocytes migration and proliferation.
In the past few decades, studies in diabetic patients with ulcers have shown numerous structural and functional abnormalities of the cutaneous microcirculation, supporting its critical role in the pathophysiology of DFUs. However, the detailed mechanisms underlying endothelial dysfunction in the skin of diabetic patients remain largely unexplored in vivo. A better understanding of the specificities of microvascular changes in the diabetic foot is essential to developing new treatments for this pressing clinical need.
Objectives are
- to explore the role of the PGI2 pathway in skin microvascular reactivity, in healthy subjects and in diabetic patients with and without DFU
- To determine the involvement of COX-1 and COX-2 in cutaneous current-induced vasodilation (CIV), in healthy subjects and in diabetic patients with and without DFU.
- To determine the involvement of sensory nerves in cutaneous CIV, in healthy subjects and in diabetic patients with and without DFU.
- To compare the function of the IP receptor between healthy subjects and diabetic patients with and without DFU.
- To determine the involvement of the nitric oxide (NO) and epoxyeicosatrienoic acids (EETs) pathway in cutaneous CIV, in healthy subjects and in diabetic patients with and without DFU.
- To assess cutaneous expression of the different components of the PGI2 pathway in the skin of healthy subjects and of diabetic patients with and without DFU.
- To assess the role of the PGI2 pathway on cell migration in vitro
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives , samples from a fourth group (patients with diabetes, neuropathy and DFU undergoing lower-limb amputation) will be collected.
| Arm | Type | Receives |
|---|---|---|
| Group 1 : healthy subject | Other | Diagnostic Test: Microdialysis, current induced vasodilation, Diagnostic Test: Skin biopsy15 healthy subject without diabetes |
| Group 2 : diabetes without ulcer | Other | Diagnostic Test: Microdialysis, current induced vasodilation, Diagnostic Test: Skin biopsy15 patients with diabetes type II and without foot ulcer |
| Group 3 : diabetes with ulcer active or <2 years | Other | Diagnostic Test: Microdialysis, current induced vasodilation, Diagnostic Test: Skin biopsy15 patients with diabetes type II and with foot ulcer (active or <2years) |
| Group 4 : Patients with type 2 diabetes, neuropathy and DFU undergoing lower limb | Other | Diagnostic Test: peri-ulcerated skin biopsyPatients with type 2 diabetes and neuropathy and DFU undergoing lower lunb surgery for skin ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Informed consent signed
- Affiliated to social security insurance or beneficiary of social security insurance
- Aged of 18 or older
- -Free from all acute and chronic pathology
- -Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA), without DFU or history of DFU
Key exclusion criteria (27 listed)
- 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.
- Presence of diabetic peripheral neuropathy above the ankle, defined as a scoring >3 of at least two of the four stimuli of the Neuropathy Disability Score (i.e. pinprick sensation, light touch, vibration, and temperature perception) (37).
- Infected wound, treated with antibiotics in the past 15 days.
- Critical ischemia of the lower limb, defined as leg pain at rest associated with ankle pressure <70 mmHg.
- History of hypersensitivity reaction to treprostinil, fluconazole, other azole compounds, L-NMMA, ketorolac, meloxicam, or any NSAIDs or acetylsalicylic acid, lidocaine (or any local anesthetic with an amide bond), or their excipients
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 |
|---|---|---|
| Microdialysis, current induced vasodilationCIV will be applied over all microdialysis fibers: one perfused with saline, one perfused with a preferential COX-1 blocker; and one perfused with a preferential COX-2 blocker. CIV will be applied over all fibers in the following conditions: one perfused with saline, one perfused with fluconazole and L-NMMA, and the last one perfused with lidocaine.Dialysate collection will be performed after each CIV: dermal PGI2 metabolite (6-ketoPGF1α) and other COX-dependent prostanoids or metabolite (e.g. 11-dehydroTXB2) will be collected in the dialysate fluid and quantified. One hour after the last condition, treprostinil will be perfused over all fibers. | Diagnostic test | Group 1 : healthy subject, Group 2 : diabetes without ulcer, Group 3 : diabetes with ulcer active or <2 years |
| Skin biopsySkin biopsy will be proposed. It will be performed on the internal superior calf (medial gastrocnemius), at a reasonable distance from the foot | Diagnostic test | Group 1 : healthy subject, Group 2 : diabetes without ulcer, Group 3 : diabetes with ulcer active or <2 years |
| peri-ulcerated skin biopsyNon-ulcerated skin from the peri-wound area will be collected. These patient will not undergo all the procedures included in this protocol. | Diagnostic test | Group 4 : Patients with type 2 diabetes, neuropathy and DFU undergoing lower limb |
Primary outcome
Exploring PGI2 pathway in skin microvascular reactivity
Time frame: Day 1
Comparison of skin perfusion measured with laser speckle contrast imaging (LSCI) on the calf, and expressed as arbitrary perfusion units, in response to local cathodal current application, between the three groups
9 secondary outcomes
Involvement of COX-1 and 2 in cutaneous current-induced vasodilation
Time frame: Day 1
Involvement of sensory nerves in cutaneous current-induced vasodilation
Time frame: Day 1
IP receptor function
Time frame: Day 1
Involvement of NO et EETs pathways in cutaneous current-induced vasodilation
Time frame: Day 1
Expression of different components of PGI2 pathway in the skin : PTGS1/2
Time frame: Day 1
Expression of different components of PGI2 pathway in the skin : PTGIS
Time frame: Day 1
Expression of different components of PGI2 pathway in the skin : PTGIR
Time frame: Day 1
Expression of different components of PGI2 pathway in the skin : TBXA2R
Time frame: Day 1
role of PGI2 pathway on cell migration in vitro
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 25617843Knebel SM, Sprague RS, Stephenson AH. Prostacyclin receptor expression on platelets of humans with type 2 diabetes is inversely correlated with hemoglobin A1c levels. Prostaglandins Other Lipid Mediat. 2015 Jan-Mar;116-117:131-5. doi: 10.1016/j.prostaglandins.2014.12.002. Epub 2015 Jan 21.
- Background: PubMed 20827283Gohin S, Sigaudo-Roussel D, Conjard-Duplany A, Dubourg L, Saumet JL, Fromy B. What can current stimulation tell us about the vascular function of endogenous prostacyclin in healthy rat skin in vivo? J Invest Dermatol. 2011 Jan;131(1):237-44. doi: 10.1038/jid.2010.267. Epub 2010 Sep 9.
- Background: PubMed 20805259Gibbons CH, Freeman R, Veves A. Diabetic neuropathy: a cross-sectional study of the relationships among tests of neurophysiology. Diabetes Care. 2010 Dec;33(12):2629-34. doi: 10.2337/dc10-0763. Epub 2010 Aug 30.
- Background: PubMed 25843412Hellmann M, Roustit M, Gaillard-Bigot F, Cracowski JL. Cutaneous iontophoresis of treprostinil, a prostacyclin analog, increases microvascular blood flux in diabetic malleolus area. Eur J Pharmacol. 2015 Jul 5;758:123-8. doi: 10.1016/j.ejphar.2015.03.066. Epub 2015 Apr 3.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data sending an e-mail to : jlcracowski@chu-grenoble.fr or mroustit@chu-grenoble.fr
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdialysis, current induced vasodilation, Skin biopsy and peri-ulcerated skin biopsy in people with Diabetes Mellitus, Type 2 and Diabetic Foot, 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 12 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia Guigui, pharmD, (+33-476-765-820, aguigui@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring PGI2 pathway in skin microvascular reactivity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099367, which also lists 4 linked publications.
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 6 Dec 2023.