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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408234
• Other study ID #: FootExercise
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2022
• Est. completion date: September 2022

Study information

• Verified date: June 2022
• Source: Universitas Sebelas Maret
• Contact: Nurhasan Agung Prabowo, MD
• Phone: 6282328010430
• Email: dr.Nurhasan21[@]staff.uns.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes Mellitus Type 2

Exclusion Criteria:

• Chronic Heart Failure
• Chronic Kidney Diseae

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Indonesia	RS UNS (Universitas Sebelas Maret Hospital)	Surakarta	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Glucose	Fasting Blood Glucose	Cange Fasting Blood Glucose in 1 weeks
Primary	Monofilament test	Monofilament test to detect diabetic neuropathy	Cange monofilament test in 1 weeks
Primary	Ankle Brachial Index	Ankle Brachial Index	Cange Ankle Brachial Index in 1 weeks