A Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis

NCT07776405 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB#: 202501843
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, double-blinded, placebo-controlled study evaluates the efficacy of a 6000 mg transdermal CBD cream in adults with plantar fasciitis. Fifty participants will apply either CBD or placebo once daily for one month.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (3)

• • Immediate pain relief, measured by change in numeric rating scale (0-10) from baseline to ten minutes after supervised application.

  Daily for one month

• • One-month changes in average daily pain score compared to baseline.

  Daily for one month

• • Global patient satisfaction

  measured using a five-point Likert scale assessing overall perceived improvement.

  Daily for one month.

Secondary Outcomes (8)

• Duration of immediate pain relief following initial application

  Daily for one month

• Adherence to protocol measured by patient logs and pump counts

  Daily for one month

• Incidence of adverse effects

  Daily for one month

• Rescue analgesic use

  Daily for one month

• Time to perceived improvement in symptoms

  Daily for one month

Study Arms (2)

Participants who receive a transdermal cannabidiol cream

EXPERIMENTAL

Dosing is three pumps per application which delivers approximately one point five milliliters of cream. Application is once daily to the most tender plantar fascia region for the entire study month

Drug: transdermal CBD cream (Tolcylen®, Marlinz Pharma)

Participants who receive a matched placebo

PLACEBO COMPARATOR

Dosing is three pumps per application which delivers approximately one point five milliliters of cream. Application is once daily to the most tender plantar fascia region for the entire study month

Drug: Matched Placebos

Interventions

transdermal CBD cream (Tolcylen®, Marlinz Pharma) DRUG

The active product is the study CBD cream supplied by the manufacturer. Dosing is three pumps per application which delivers approximately one point five milliliters of cream. Application is once daily to the most tender plantar fascia region for the entire study month. The first dose will be taught and supervised in clinic using a glove. The cream will be massaged into the affected area for at least forty-five seconds. Skin must be clean and dry before application. No other topical agents may be placed on the study area during the study period.

Participants who receive a transdermal cannabidiol cream

Matched Placebos DRUG

The control group will receive a placebo cream identical in appearance, texture, scent, and packaging to the active product but containing no cannabidiol.

Participants who receive a matched placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-85
• Clinical diagnosis of plantar fasciitis by a qualified provider
• Symptomatic for at least four weeks with plantar heel pain consistent with plantar fascia involvement
• Baseline average pain score that meets eligibility threshold as defined in the protocol (?)
• Willing to apply assigned cream once daily and attend needed visits (?)

You may not qualify if:

• Special populations and consent limitations. Pregnancy, breastfeeding, prisoners, inability to provide informed consent, or inability to complete study procedures
• Contraindications to topical products or CBD. History of allergy or sensitivity to cannabinoids, excipients, or topical creams used in the study
• Confounding dermatologic conditions at the application site. Open wounds, active infection, dermatitis, ulceration, or recent burns on the heel or midfoot
• Recent or planned procedures that alter outcomes. Corticosteroid injection, platelet rich plasma, surgery, immobilization, or shockwave therapy within the protocol washout window
• Concurrent therapies that confound pain outcomes. Routine use of systemic opioids, regular use of nonsteroidal anti-inflammatory drugs beyond rescue parameters, new analgesic starts during the study, or use of other topical analgesics on the study area

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Department of Orthopaedics

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Central Study Contacts

Antony Merendino, DPM

CONTACT

352-273-7044; merena@ortho.ufl.edu

Shea Herlihy, MS

CONTACT

352-273-7361; herliso@ortho.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)