NCT07060352

Brief Summary

The gastrocnemius muscles, which form the upper part of the calf, can suffer from retraction, a common but often under-diagnosed condition, which can be a risk factor for plantar fasciitis. Retraction can be treated medically, by stretching, or surgically, by lengthening the muscles. Gastrocnemius retraction is difficult to measure, but tests such as the Ankle Dorsiflexion Index (ADI) provide a more accurate assessment. Knowing the prevalence of this retraction in patients suffering from plantar fasciitis would enable us to improve diagnostic criteria and better target treatments. Surgical lengthening of the gastrocnemius, particularly by tenotomy, is effective in cases of chronic plantar fasciitis, even without apparent muscle retraction.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Sep 2025

Longer than P75 for not_applicable

Status
not yet recruiting

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

Study Progress19%
Sep 2025Mar 2029

First Submitted

Initial submission to the registry

June 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

June 23, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of gastrocnemius muscle retraction in patients with plantar fasciitis

    retraction of the gastrocnemius muscles will be defined by an ADI of less than 13° measured by a digital inclinometer

    At Day 0

Secondary Outcomes (12)

  • correlation between ADI measurement and Manchester Oxford Foot Questionnaire (MOXFQ)

    At Day 0

  • correlation between ADI measurement and pain Visual Analog Scale (VAS)

    At Day 0

  • Evolution of Visual Analog Scale (VAS)

    between Day 0 and Week 8

  • Evolution of Visual Analog Scale (VAS)

    between Day 0 and Week 16

  • Evolution of Visual Analog Scale (VAS)

    between Day0 and Week 24

  • +7 more secondary outcomes

Study Arms (1)

Ankle Dorsiflexion Index (ADI) measurement

EXPERIMENTAL

Ankle Dorsiflexion Index (ADI) measurement at D0 and W8

Diagnostic Test: Ankle Dorsiflexion Index (ADI) measurement

Interventions

Ankle Dorsiflexion Index (ADI) measurement at D0 and W8

Ankle Dorsiflexion Index (ADI) measurement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged 70 or under
  • Patient suffering from unilateral plantar fasciitis that has progressed for more than 6 months and is recalcitrant to medical treatment
  • Collection of express, oral consent
  • Available for follow-up visits

You may not qualify if:

  • Patients with neuropathic pain
  • History of fracture of the lower limb, surgery on the lower limb, inflammatory rheumatism of the lower limb, injury to the Achilles tendon
  • Patient with another painful orthopedic lesion of the legs/feet
  • Persons unable to give consent
  • Not affiliated to a social security scheme
  • Persons under court protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 11, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

July 11, 2025

Record last verified: 2025-07