Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients

Phase 1

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Smart Foot Exercise

• Registration Number: NCT05408234
• Lead Sponsor: Universitas Sebelas Maret

Brief Summary

Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after

Detailed Description

Use an 8-10 MHz Doppler probe with a gel smeared over the sensor. Place the Doppler probe on the pulse area at a 45-60° angle to the skin surface.

Move the probe to find the most precise and robust arterial pulse before inflating the cuff.

The cuff is inflated about 20 mm Hg above the point where the arterial Doppler sound disappears.

Then slowly deflate until the Doppler sound reappears and records this value. The blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel.

If the flow is still detected at the maximum inflation rate (300 mmHg), the cuff should be deflated immediately to avoid pain.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diabetes Mellitus Type 2

Exclusion Criteria

• Chronic Heart Failure
• Chronic Kidney Diseae

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smart Foot Exercise	Smart Foot Exercise	The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale). The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red. The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day. Movement using newspaper media, namely by: Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet. The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose	Cange Fasting Blood Glucose in 1 weeks	Fasting Blood Glucose
Monofilament test	Cange monofilament test in 1 weeks	Monofilament test to detect diabetic neuropathy
Ankle Brachial Index	Cange Ankle Brachial Index in 1 weeks	Ankle Brachial Index

Trial Locations

Locations (1)

RS UNS (Universitas Sebelas Maret Hospital); 🇮🇩 Surakarta, Central Java, Indonesia