Cutaneous Microcirculation in Vascular DiseasesNCT01235312
Microcirculatory Mapping of the Aging Hand and Foot
An observational study of Cutaneous Microcirculation in Vascular Diseases, run by Hannover Medical School at 1 site in Germany.
Trial summary
Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to address this highly visible area, although no specific statistics concerning the number of patients undergoing dorsal hand rejuvenation have been published yet. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Microcirculation in Vascular Diseases
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to May 2011
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease
Who may be able to join
- Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease aged between 18 and 75 years
Who cannot join
- soft tissue inflammation or osteomyelitis, liver disease, cardiac dysfunction, arterial hypotension
Trial locations and contacts
1 site in 1 country.
About this study
Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to address this highly visible area, although no specific statistics concerning the number of patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above mentioned therapies have been reported in the literature, but still there is a lack of scientific literature about functional microcirculation of the dorsum of the hand.
Furthermore, there is a lack of scientific data about functional microcirculation of the plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation of the functional microcirculation of hands and feet in healthy subjects as well as patients suffering from the above mentioned diseases.
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 |
|---|---|---|
| Healthy subjects | Not described | |
| Patients suffering from Diabetes mellitus | Not described | |
| Patients suffering from peripheral arterial occlusive disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of microcirculation to age and incidence of vascular diseases
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Microcirculation in Vascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235312
- Sponsor's protocol ID
- Kraemer003
- Status last verified
- Jun 2011
- First submitted
- 4 Nov 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Mapping of the Aging Hand and Foot
- ClinicalTrials.gov ID
- NCT01235312
- Acronym / sponsor ID
- Kraemer003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Nov 2010 (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.
Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to address this highly visible area, although no specific statistics concerning the number of patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above mentioned therapies have been reported in the literature, but still there is a lack of scientific literature about functional microcirculation of the dorsum of the hand.
Furthermore, there is a lack of scientific data about functional microcirculation of the plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation of the functional microcirculation of hands and feet in healthy subjects as well as patients suffering from the above mentioned diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | – |
| Patients suffering from Diabetes mellitus | – | – |
| Patients suffering from peripheral arterial occlusive disease | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease
Key inclusion criteria (1 listed)
- Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease aged between 18 and 75 years
Key exclusion criteria (1 listed)
- soft tissue inflammation or osteomyelitis, liver disease, cardiac dysfunction, arterial hypotension
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
Correlation of microcirculation to age and incidence of vascular diseases
Time frame: 7 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 22 Jun 2011.
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?
An observational study of Cutaneous Microcirculation in Vascular Diseases, run by Hannover Medical School at 1 site in Germany.
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 1 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 22 Jun 2011. 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 Germany. 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?
Correlation of microcirculation to age and incidence of vascular diseases (time frame: 7 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 22 Jun 2011.