Plantar FasciitisPhase 2NCT07776405
A Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis
A Phase 2 study testing transdermal CBD cream (Tolcylen®, Marlinz Pharma) in people with Plantar Fasciitis, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- transdermal CBD cream (Tolcylen®, Marlinz Pharma)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 (?)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Florida Department of Orthopaedics
Gainesville, Florida, 32611
Antony Merendino, DPM, 352-273-7044, merena@ortho.ufl.edu
Shea Herlihy, MS, 352-273-7361, herliso@ortho.ufl.edu
About this study
Official title: Topical Cannabidiol for Plantar Fasciitis: A Double-Blinded Study on Rapid and Sustained Pain Relief
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.
Read the detailed description
Plantar fasciitis is one of the most common causes of plantar heel pain, affecting millions of adults annually and accounting for a large proportion of musculoskeletal complaints seen in orthopaedic and sports medicine clinics. The condition is typically caused by repetitive microtrauma and inflammation at the plantar fascia's insertion on the calcaneus, leading to chronic pain, functional impairment, and limitations in daily activities. Despite its prevalence, effective and well-tolerated long-term treatments remain limited. Current management strategies, including stretching, orthotics, corticosteroid injections, and physical therapy, often provide only temporary relief or are associated with adverse effects from repeated use.
Cannabidiol (CBD), a non-psychoactive phytocannabinoid derived from hemp, has gained attention for its potential anti-inflammatory and analgesic properties. Preclinical and clinical studies have demonstrated CBD's ability to modulate inflammatory markers, reduce cytokine activity, and improve pain perception in various musculoskeletal and neuropathic conditions. These mechanisms make it a promising candidate for targeting inflammation-driven pain disorders such as plantar fasciitis. Although CBD has been studied for arthritis, tendon injuries, and generalized pain syndromes, no published trials have yet evaluated its efficacy in plantar fasciitis specifically.
A recent scoping review on topical CBD interventions confirmed this absence of evidence, highlighting a significant gap in the current literature regarding CBD's role in localized foot and heel pain. This lack of research underscores an unmet clinical need to assess whether transdermal delivery of CBD could provide measurable short- and long-term benefits in patients with plantar fasciitis.
This study aims to address that gap by evaluating a 6000 mg transdermal CBD cream (Tolcylen®, Marlinz Pharma) for both immediate and sustained pain reduction in adults with plantar fasciitis. By using a randomized, double-blinded, placebo-controlled design, we intend to determine whether topical CBD can offer a safe, non-invasive, and effective alternative or adjunct to current treatments. The results of this investigation may contribute to the emerging evidence on topical cannabinoids in orthopaedic pain management and inform future clinical practice guidelines.
- Conditions
- Plantar Fasciitis
- Being tested
- transdermal CBD cream (Tolcylen®, Marlinz Pharma), Matched Placebos
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Matched PlacebosDrug
The control group will receive a placebo cream identical in appearance, texture, scent, and packaging to the active product but containing no cannabidiol.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Matched Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Immediate pain relief, measured by change in numeric rating scale (0-10) from baseline to ten minutes after supervised application.
Measured: Daily for one month
• One-month changes in average daily pain score compared to baseline.
Measured: Daily for one month
• Global patient satisfaction
measured using a five-point Likert scale assessing overall perceived improvement.
Measured: Daily for one month.
Secondary outcomes (8)
Duration of immediate pain relief following initial application
Measured: Daily for one month
Adherence to protocol measured by patient logs and pump counts
Measured: Daily for one month
Incidence of adverse effects
Occurrence of negative side effects
Measured: Daily for one month
Rescue analgesic use
Measured: Daily for one month
Time to perceived improvement in symptoms
Measured: Daily for one month
6. PROMIS Pain Interference questionnaire
Measured: At enrollment and at end of once month
7. Foot Function Index questionnaires
Measured: At enrollment and at one month
8. Return to normal activity - the number of days required for participants to resume full standing or walking tolerance without pain
Measured: Once during one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776405
- Sponsor's protocol ID
- IRB#: 202501843
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No