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Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence

NCT04624516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-10

No results posted yet for this study

Summary

The incidence of diabetic foot ulcer recurrence in one year can reach 35%. Plantar foot diabetic foot ulcer is the most frequently diabetic foot ulcer recurrence. The recurrence incidence can occur at least 14 days after the diabetic foot ulcer has healed. Physical activity and exercise are highly recommended for the prevention of diabetic foot ulcers. The study about the form of foot exercise to prevent a diabetic foot ulcer recurrence is still unclear. The major hypothesis was there is an effect of self-structured foot exercise on the plantar foot diabetic ulcer recurrences. The minor hypothesis was (1) The improvement of HbA1c, ABI, diabetic neuropathy examination score, callus, and walking speed can decrease the incidence of plantar foot diabetic ulcer (2) a self-structured foot exercise can decrease the incidence and the speed of incidence plantar doot diabetic ulcer recurrence. Participants were randomized into two groups: Exercise group (n=25) and control group (n=25). The exercise is the combination of flexibility and resistance exercise using a flexible band in 24 weeks. The incidence of plantar diabetic foot ulcers was monitored through the research process.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot

Interventions

OTHER

self-structured foot exercise

The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a flexible band with difference thickness (0,5 mm in the first 12 weeks and 0,65 mm in the second 12 weeks)

Sponsors & Collaborators

  • Maria Suryani

    lead OTHER

Principal Investigators

  • Maria Suryani · St. Elisabeth School Health Science (STIKES St Elisabeth Semarang)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2020-07-30
Completion
2020-07-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624516 on ClinicalTrials.gov