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

Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384758
• Other study ID #: Perfusion under Compression
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2020
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Leg Edema
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Compression 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.

Locations

Country	Name	City	State
Germany	University of Erlangen, Vascular Surgery	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	sO2	The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2	12 Months
Primary	Flow	The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow	12 Months
Primary	rHb	The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb	12 Months