Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema
Conditions
Keywords
Compression therapy, Microcirculation, Diabetes mellitus, Peripheral Arterial Disease
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).
Interventions
DEVICECompression Therapy
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.
Sponsors
University Hospital Erlangen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by questionnaire | 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 | 12 Months | The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2 |
| Flow | 12 Months | The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow |
| rHb | 12 Months | The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb |
Countries
Germany
Outcome results
None listed