NCT06064721

Brief Summary

This randomized control trial aims to compare peripheral circulation in type 2 diabetes mellitus. This study aims to determine the effect of the Buerger-Allen exercise (BAE) on peripheral circulation among patients with type 2 diabetes mellitus visited in outpatients department Participants will perform the Buerger -Allen exercise with routine care control group: Researchers will compare with routine care

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

September 26, 2023

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • peripheral circulation

    peripheral circulation measure by perfusion index

    total 21 days (baseline line, 6th day, and after15th day

Study Arms (2)

Buerger-Allen Exercise Group

EXPERIMENTAL

The researcher will conduct training sessions on the BAE for the study group (how to perform these exercises, duration, and frequency of exercise). Firstly researcher practically demonstrate the BAE technique lasting 15-20 minutes, and secondly will encourage each participant to re-demonstrate the following technique. The researcher will ensure that the study group practices the exercise until they demonstrate competence in its execution. Additionally, the study group will be provided with a photographic brochure illustrating the exercise. The buerger Allen exercise will consist of three steps step 1. Elevation step 2. Dependency step 3. Horizontal The intervention group will continue for 51 days, with a 6-8 hour gap between the two sessions, in addition to receiving routine care. To ensure exercise continuity, participants will receive reminders via phone calls/messages

Other: Buerger-Allen Exercise

Routine Care Group

NO INTERVENTION

the control group participants will receive routine care.

Interventions

Buerger-Allen exercise will be taught by researcher and perform by patient at home twice a day

Buerger-Allen Exercise Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with Type 2 diabetes mellitus
  • Participants who have an age group of 35-65 years
  • Participants who are using insulin for the last 5 years

You may not qualify if:

  • Participants with a history of deep vein thrombosis
  • Patients who have undergone recent surgeries on the lower extremities
  • Participants with severe comorbidities, such as uncontrolled hypertension or heart failure
  • Participants with cognitive impairments that hinder their ability to understand and perform the exercises safely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ hospital, sheikhupura

Sheikhupura, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Buerger-Allen exercise and Routine care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

August 7, 2025

Primary Completion

November 1, 2025

Study Completion

November 10, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations