A clinical trial to study the effects of two foot insoles, customized total contact insole and silicone insole in patients with plantar fasciitis.

Effect of customized total contact insoles and silicone insoles in individuals with plantar fasciitis- A comparative study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058929

Enrollment

Registered

2023-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M722- Plantar fascial fibromatosis

Interventions

Intervention1: total contact insole: It is made up of ethylene vinyl acetate.Total contact insoles can redistribute plantar pressure and transfer pressure from the rear foot to the midfoot region. Int

Eligibility

Inclusion criteria

Inclusion criteria: a. Subject age between 18 to 60 years b. Unilateral involvement of plantar fasciitis c. Heel Pain more than 4 on VAS scale attached in. d. History of Plantar Heel pain for at least 1 month

Exclusion criteria

Exclusion criteria: a. Previous surgical intervention of foot b. Acute heel trauma due to fall or any injury. c. Flat feet d. Plantar fasciitis due to systemic rheumatic disease, neuropathic pain or any local infection. e. Pregnancy f. Coagulation disorders

Design outcomes

Primary

Measure	Time frame
The Foot & Ankle Outcome Score (FAOS) will be used to assess the outcome of orthotic insoles. It consists of 42 questions, divided into five subscales- pain, symptoms, activities of daily living (ADL), quality of life (QOL) & sports & recreation. Each question gets a score from 0 to 4 on a Likert scale, & the raw subscale scores are calculated from the sum of individual scores. The subscale scores are converted into normalized score out of 100, whereby 100 depicts normal function & 0 represents extreme dysfunction.Timepoint: 3 weeks with orthosis	—

Measure

Time frame

The Foot & Ankle Outcome Score (FAOS) will be used to assess the outcome of orthotic insoles. It consists of 42 questions, divided into five subscales- pain, symptoms, activities of daily living (ADL), quality of life (QOL) & sports & recreation. Each question gets a score from 0 to 4 on a Likert scale, & the raw subscale scores are calculated from the sum of individual scores. The subscale scores are converted into normalized score out of 100, whereby 100 depicts normal function & 0 represents extreme dysfunction.Timepoint: 3 weeks with orthosis

—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactVivek Kumar

Pandit Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan)

tarun.pno@gmail.com9969291163

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026