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

Sponsor

University Hospital Erlangen (Other)

Overall Status

Completed

CT.gov ID

NCT03384758

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Diabetes Mellitus Leg Edema	Device: Compression Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Erlangen, Vascular Surgery	Erlangen		Germany	91054

Sponsors and Collaborators

University Hospital Erlangen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulrich Rother, Principal investigator PD Dr. med. Ulrich Rother, University Hospital Erlangen

ClinicalTrials.gov Identifier:

NCT03384758

Other Study ID Numbers:

Perfusion under Compression

First Posted:

Dec 27, 2017

Last Update Posted:

May 8, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ulrich Rother, Principal investigator PD Dr. med. Ulrich Rother, University Hospital Erlangen

Compression therapy

Microcirculation

Diabetes mellitus

Peripheral Arterial Disease

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Diabetes Mellitus

Study Results

No Results Posted as of May 8, 2020