NCT05432895

Brief Summary

The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress96%
Oct 2023Jun 2026

First Submitted

Initial submission to the registry

May 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2026

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

May 4, 2022

Last Update Submit

June 11, 2025

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (3)

  • NO pain at 1 month follow up

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

    1 months

  • NO pain at 3 months follow up

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

    3 months

  • NO pain at 6 months follow up

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

    6 months

Secondary Outcomes (3)

  • Clinically relevant change in Foot Function Index (FFI)

    1 months

  • Clinically relevant change in Foot Function Index (FFI)

    3 months

  • Clinically relevant change in Foot Function Index (FFI)

    6 months

Study Arms (2)

Control( static splinting)

ACTIVE COMPARATOR

conventional static splint

Device: Dynamic splint

Experiment( dynamic splinting)

EXPERIMENTAL

Device treats plantar fasciitis and replacing boot immobilization

Device: Dynamic splint

Interventions

Dynamic splintDEVICE

Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Control( static splinting)Experiment( dynamic splinting)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Demographic - Over 18 years of age and ambulatory without a gait aid with no history of narcotic use
  • Diagnosis - Unilateral or bilateral acute (\< 6 months of pain) plantar fasciitis (i.e., Heel pain that increases with weightbearing, "First step pain": heel pain that occurs after a period of non-weightbearing, such as in the morning when arising from bed or when arising after prolonged sitting; the pain is improved after a few minutes walking but will worsen again with prolonged weightbearing, tenderness over the medial calcaneal tuberosity at the insertion of the plantar fasciitis)
  • Permitted - Icing, NSAIDS( ibuprofen), Custom Shoe Inserts, Diagnostic Ultrasound

You may not qualify if:

  • Demographic - Under 18 year of age, requires a gait aid for ambulation; if not covered by insurance,
  • Diagnosis of - Arthritis of the Ankle, Midfoot, or Forefoot; Inflammatory Arthritis; Gout; Turf Toe; Hallux Rigidus; Hallux Limitus; Sesamoiditis; Tendonitis or Tendinopathy; Prior tear or Rupture of the Plantar Fascia; Fibromyalgia, Neuralgia, or Neuropathy; Peripheral Vascular Disease; Prior Trauma to the Heel, Fracture of the Calcaneus; Infection; Corn; Callus; Ingrown Nail.
  • Patient with history of Symptoms for over 6 months
  • Refractory to prior splint-based treatments
  • Prior injection of the plantar fascia
  • Prior surgery on the plantar fascia
  • Narcotic use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Palo Alto, California, 94063, United States

RECRUITING

Stanford outpatient center

Redwood City, California, 84063, United States

RECRUITING

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Central Study Contacts

Prerna Arora

CONTACT

6507217631arprerna@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2022

First Posted

June 27, 2022

Study Start

October 31, 2023

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations

US(2)