Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- University Hospital Erlangen
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Flow
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
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).
Investigators
Ulrich Rother
Principal investigator PD Dr. med. Ulrich Rother
University Hospital Erlangen
Eligibility Criteria
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
Exclusion Criteria
- •Study-Arm PAD:
- •Critical limb ischemia
- •ABI \< 0.6
- •simoultaneous Diabetes Mellitus
- •Study-Arm Diabetes:
- •Wagner Score \>0
- •Pallasthesie \<6
Outcomes
Primary Outcomes
Flow
Time Frame: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow
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)
rHb
Time Frame: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb
sO2
Time Frame: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2