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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Peripheral Arterial Disease; Leg Edema
• Intervention / Treatment: Device: Compression Therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University of Erlangen, Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mild to moderate PAD	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.
Active Comparator: Diabetes mellitus	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.
Placebo Comparator: Healthy volunteers	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Erlangen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Microcirculation; Peripheral Arterial Disease; Compression therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Atherosclerosis; Diabetes Mellitus; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: Perfusion under Compression

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No