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

NCT04624516 | Completed

• 1 other identifier: 4477112020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetic foot ulcer; diabetes melitus; ankle brachial index; diabetic neuropathy; exercise

Outcome Measures

Primary Outcomes (3)

• The number of plantar foot diabetic ulcer recurrence incidence

  The number of plantar foot diabetic ulcer recurrence incidence after healing of the last plantar foot diabetic ulcer at least 1 month. The measurement of diabetic foot ulcer by the specialist doctor using Wagner diabetic ulcer classification

  up to 12 weeks

• The number of plantar foot diabetic ulcer recurrence incidence

  The number of plantar foot diabetic ulcer recurrence incidence after healing of the last plantar foot diabetic ulcer at least 1 month. The measurement of diabetic foot ulcer by the specialist doctor using Wagner diabetic ulcer classification

  up to 24 weeks

• The time of plantar foot diabetic ulcer recurrence incidence

  The time of plantar foot diabetic ulcer recurrence incidence is found after healing of the last plantar foot diabetic ulcer at least 1 month.

  up to 24 weeks

Secondary Outcomes (5)

• change of ankle brachial index (ABI)

  from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks

• change of HbA1c level

  from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks

• change of diabetic neuropathy examination (DNE) score

  from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks

• change of walking speed

  from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks

• callus

  from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

The group received training in self-structured foot exercise and they were encouraged to do self-structure foot exercise 3 times a week. They received usual care

Other: self-structured foot exercise

Control Group

NO INTERVENTION

the group received usual care

Interventions

self-structured foot exercise OTHER

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)

Also known as: foot exercise, flexibility and resistance foot exercise

Intervention group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• signed an informed consent
• aged 40-60 years
• can walk within 5 meters
• recently healed plantar foot diabetic ulcer (1-12 months)

You may not qualify if:

• post amputation of right and left lower limb
• contracture of lower limb
• parkinson's
• osteomyelitis history
• paralysis

Sponsors & Collaborators

• Maria Suryani: lead

Study Sites (1)

St Elisabeth School Health Science (STIKES St. Elisabeth Semarang)

Semarang, Central Java, 50252, Indonesia

Location

Related Publications (31)

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• Suryani M, Samekto W, Heri-Nugroho, Susanto H, Dwiantoro L. Effect of foot-ankle flexibility and resistance exercise in the secondary prevention of plantar foot diabetic ulcer. J Diabetes Complications. 2021 Sep;35(9):107968. doi: 10.1016/j.jdiacomp.2021.107968. Epub 2021 May 28.

  PMID: 34187716 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies; Motor Activity

Interventions

Pliability

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Maria Suryani

  St. Elisabeth School Health Science (STIKES St Elisabeth Semarang)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator didn't know the groups. The assessor didn't know the groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD (candidate)

Model Details: The exercise group was trained structured foot exercise and they did the exercise independently until 24 weeks or until the recurrence occurred The control group had usual care

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 10, 2020
• Study Start: September 4, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: anytime
• Access Criteria: mariahandoko22@gmail.com

Locations

ID (1)