Hypertensive Ischemic Leg UlcerNCT01578382
Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)
An observational study of Hypertensive Ischemic Leg Ulcer and Calciphylaxis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects. Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hypertensive Ischemic Leg Ulcer, Calciphylaxis
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to Dec 2019
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: n=20: Having Martorell hypertensive ischemic leg ulcer (as defined above) or n=10: Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or n=20: Having a venous ulcer (as defined above) (controls)
Who may be able to join
- Having Martorell hypertensive ischemic leg ulcer (as defined above) or
- Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or
- Having a venous ulcer (as defined above)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital of Zurich
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)
Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects.
Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.
Read the detailed description
Comparative study including
- 20 consecutive patients with Martorell HYTILU
- 10 consecutive patients with Calciphylaxis (calcific uremic arteriolopathy)
- 20 patients with venous ulcer
The following parameters are measured in the blood serum:
White blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium; phosphate; albumin; 25-hydroxyvitamin-D; 1-25-dihydroxyvitamin-D; homocysteine; cystatin C alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)
The following parameters are measured in samples of diseased (necrobiotic) skin:
alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)
- Conditions
- Hypertensive Ischemic Leg Ulcer, Calciphylaxis
- Keywords
- Martorell hypertensive ischemic leg ulcer, Calciphylaxis (calcific uremic arteriolopathy), Ischemic subcutaneous arteriolosclerosis, Hypertension, Diabetes, Medial calcinosis, Wound healing
- Medical subject headings
- Calciphylaxis, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive ischemic leg ulcer | Twenty consecutive patients with Martorell HYTILU as defined in: Arch Dermatol 2010;146:961-968 | |
| Calciphylaxis | Ten subjects with calciphylaxis (calcific uremic arteriolopathy) as described in: Vasa 1998;27:137-143 | |
| Venous ulcer (controls) | Twenty subjects with venous ulcers (CEAP C4-6) as described in: J Vasc Surg. 2004 Dec;40(6):1248-52 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification
Comparison of the calcification-protective factors GLA-1(serum protein alpha2-Heremans-Schmid glycoprotein/fetuin A), Osteoprotegerin, Fibroblast Growth Factor 23, and Alphafetoin in:
- Martorell HYTILU (A1)
- Calciphylaxis (calcific uremic arteriolopathy)(A2)
- Venous ulcers (as control group)(B)
Measured: 36 months
Secondary outcomes (1)
Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation
Comparison of C-reactive protein, procalcitonin and white blood cell count in:
- Martorell HYTILU (A1)
- Calciphylaxis (calcfic uremic arteriolopathy) (A2)
- Venous ulcers (control group) (B)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Ischemic Leg UlcerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürg Hafner, Professor, Principal investigator, Department of Dermatology, University Hospital of Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578382
- Sponsor's protocol ID
- KEK-ZH-NR2010-0433/0
- Status last verified
- Jun 2021
- First submitted
- 2 May 2011
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)
- ClinicalTrials.gov ID
- NCT01578382
- Acronym / sponsor ID
- KEK-ZH-NR2010-0433/0
- Conditions
- Hypertensive Ischemic Leg Ulcer, Calciphylaxis
- Keywords
- Martorell hypertensive ischemic leg ulcer, Calciphylaxis (calcific uremic arteriolopathy), Ischemic subcutaneous arteriolosclerosis, Hypertension, Diabetes, Medial calcinosis, Wound healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Apr 2012 (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.
Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects.
Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.
Detailed description
Comparative study including
- 20 consecutive patients with Martorell HYTILU
- 10 consecutive patients with Calciphylaxis (calcific uremic arteriolopathy)
- 20 patients with venous ulcer
The following parameters are measured in the blood serum:
White blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium; phosphate; albumin; 25-hydroxyvitamin-D; 1-25-dihydroxyvitamin-D; homocysteine; cystatin C alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)
The following parameters are measured in samples of diseased (necrobiotic) skin:
alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertensive ischemic leg ulcer | – | –Twenty consecutive patients with Martorell HYTILU as defined in: Arch Dermatol 2010;146:961-968 |
| Calciphylaxis | – | –Ten subjects with calciphylaxis (calcific uremic arteriolopathy) as described in: Vasa 1998;27:137-143 |
| Venous ulcer (controls) | – | –Twenty subjects with venous ulcers (CEAP C4-6) as described in: J Vasc Surg. 2004 Dec;40(6):1248-52 |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- n=20: Having Martorell hypertensive ischemic leg ulcer (as defined above) or n=10: Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or n=20: Having a venous ulcer (as defined above) (controls)
Key inclusion criteria (3 listed)
- Having Martorell hypertensive ischemic leg ulcer (as defined above) or
- Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or
- Having a venous ulcer (as defined above)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification
Time frame: 36 months
Comparison of the calcification-protective factors GLA-1(serum protein alpha2-Heremans-Schmid glycoprotein/fetuin A), Osteoprotegerin, Fibroblast Growth Factor 23, and Alphafetoin in: * Martorell HYTILU (A1) * Calciphylaxis (calcific uremic arteriolopathy)(A2) * Venous ulcers (as control group)(B)
1 secondary outcome
Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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.
Jürg Hafner, Professor principal investigator
Department of Dermatology, University Hospital of Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Ischemic Leg Ulcer and Calciphylaxis, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2021. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification (time frame: 36 months). 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 18 Jun 2021.