Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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).

Official Title
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Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.

Conditions
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Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema

Intervention / Treatment
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* Device: Compression Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: leg edema Diabetes mellitus Typ 2 (history of longer than 2 years) palpable foot pulses Pallaesthesie >6 Wagner Score 0 Exclusion Criteria: Study-Arm PAD: Critical limb ischemia ABI < 0.6 simoultaneous Diabetes Mellitus Study-Arm Diabetes: Wagner Score >0 Pallasthesie <6

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mild to moderate PAD<br> | Device: Compression Therapy<br>* 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.<br>|
| Active Comparator: Diabetes mellitus<br> | Device: Compression Therapy<br>* 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.<br>|
| Placebo Comparator: Healthy volunteers<br> | Device: Compression Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression therapy, Microcirculation, Diabetes mellitus, Peripheral Arterial Disease