Peripheral Arterial DiseaseNCT03384758
Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus
A study testing Compression Therapy in people with Peripheral Arterial Disease and Diabetes Mellitus, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema
- What is being tested?
- Compression Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2018to 1 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study-Arm PAD:
- leg edema
- symptomatic PAD (Fontaine stage II)
- no palpable foot pulses
- ABI <0.9 and >0.6, absolute ankle pressure > 60mmHg
- Study-Arm Diabetes:
Show all 11Show fewer
- leg edema
- Diabetes mellitus Typ 2 (history of longer than 2 years)
- palpable foot pulses
- Pallaesthesie >6
- Wagner Score 0
Who cannot join
- Study-Arm PAD:
- Critical limb ischemia
- ABI < 0.6
- simoultaneous Diabetes Mellitus
- Study-Arm Diabetes:
- Wagner Score >0
- Pallasthesie <6
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
Read the detailed description
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.
Therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema
- Being tested
- Compression Therapy
- Keywords
- Compression therapy, Microcirculation, Diabetes mellitus, Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression TherapyDevice
Therapy of the leg edema with compression stockings class I for three hours, after a short break with compression stocking class II for again three hours.
| Study group | Role | What they receive |
|---|---|---|
| mild to moderate PAD | Active comparator | Not described Receives: Device: Compression Therapy |
| Diabetes mellitus | Active comparator | Not described Receives: Device: Compression Therapy |
| Healthy volunteers | Placebo comparator | Not described Receives: Device: Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by questionnaire
The Adverse Events are defined in the questionnaire as: Abort of the Therapy, Pressure marks, Quantification of the wearing comfort (Points 1-10), subjective reduction of the leg edema (Points 1-10)
Measured: 12 Months
sO2
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2
Measured: 12 Months
Flow
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow
Measured: 12 Months
rHb
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 May 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384758
- Sponsor's protocol ID
- Perfusion under Compression
- Status last verified
- May 2020
- First submitted
- 12 Dec 2017
- Last updated
- 8 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rother U, Grussler A, Griesbach C, Almasi-Sperling V, Lang W, Meyer A. Safety of medical compression stockings in patients with diabetes mellitus or peripheral arterial disease. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001316. doi: 10.1136/bmjdrc-2020-001316.
PubMed 32503811
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT03384758
- Acronym / sponsor ID
- Perfusion under Compression
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema
- Keywords
- Compression therapy, Microcirculation, Diabetes mellitus, Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 Dec 2017 (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.
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
Detailed description
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.
Therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild to moderate PAD | Active comparator | Device: Compression Therapy |
| Diabetes mellitus | Active comparator | Device: Compression Therapy |
| Healthy volunteers | Placebo comparator | Device: Compression Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- leg edema
- symptomatic PAD (Fontaine stage II)
- no palpable foot pulses
- ABI <0.9 and >0.6, absolute ankle pressure > 60mmHg
- leg edema
Key exclusion criteria (7 listed)
- Critical limb ischemia
- ABI < 0.6
- simoultaneous Diabetes Mellitus
- Wagner Score >0
- Pallasthesie <6
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 |
|---|---|---|
| Compression TherapyTherapy of the leg edema with compression stockings class I for three hours, after a short break with compression stocking class II for again three hours. | Device | Diabetes mellitus, Healthy volunteers, mild to moderate PAD |
Primary outcome
Number of participants with treatment-related adverse events as assessed by questionnaire
Time frame: 12 Months
The Adverse Events are defined in the questionnaire as: Abort of the Therapy, Pressure marks, Quantification of the wearing comfort (Points 1-10), subjective reduction of the leg edema (Points 1-10)
sO2
Time frame: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2
Flow
Time frame: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow
rHb
Time frame: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb
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 8 May 2020.
- Derived from this study: PubMed 32503811Rother U, Grussler A, Griesbach C, Almasi-Sperling V, Lang W, Meyer A. Safety of medical compression stockings in patients with diabetes mellitus or peripheral arterial disease. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001316. doi: 10.1136/bmjdrc-2020-001316.
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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 study testing Compression Therapy in people with Peripheral Arterial Disease and Diabetes Mellitus, run by University Hospital Erlangen 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 11 inclusion and 7 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 8 May 2020. 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. 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.
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?
Number of participants with treatment-related adverse events as assessed by questionnaire (time frame: 12 Months). The study lists 4 primary outcomes in all. 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 NCT03384758, which also lists 1 linked publication.
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 8 May 2020.