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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild to moderate PAD | Active Comparator |
| |
| Diabetes mellitus | Active Comparator |
| |
| Healthy volunteers | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 Months |
| sO2 | The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2 | 12 Months |
| Flow | The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow | 12 Months |
| rHb | The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb | 12 Months |
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Inclusion Criteria:
Study-Arm PAD:
Study-Arm Diabetes:
Exclusion Criteria:
Study-Arm PAD:
Study-Arm Diabetes:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Erlangen, Vascular Surgery | Erlangen | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32503811 | Derived | 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. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |