A Phase 2 interventional study of transdermal CBD cream (Tolcylen®, Marlinz Pharma) and Matched Placebos in Plantar Fasciitis, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
Among 45 studies in Fasciitis, Plantar with a site in United States — 6 open to participants now, 6 under way, none of them phase 3. Fasciitis, Plantar · United States.
Among the 45 studies in Fasciitis, Plantar with a site in United States, this one is the 23rd largest by planned enrollment of the 44 interventional ones that give a count, is one of 2 that started in 2026, is one of 7 in phase 2, and was the 45th registered.
223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.
This study's planned enrollment of 50 is below the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.
Browse Fasciitis, Plantar studies →6 of the 45 studies in Fasciitis, Plantar with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 29 Fasciitis, Plantar studies recruiting now, 5 (17%) set no upper age limit and 21 (72%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →45 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
Median enrollment 55 across the 44 interventional studies, 43 across the 1 observational. Of the 32 that completed or were terminated, 10 (31%) have results posted.
18 of 45 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
University of Florida has 2 studies filed under Fasciitis, Plantar — fewer than ten, so there is no comparison to draw.
3 of the studies in Fasciitis, Plantar with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05075005University of FloridaThe Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis | 2027-01-20 |
| NCT07395128Joint & Vascular InstituteLateral Plantar Artery Embolization For Plantar Fasciitis | 2027-03 |
| NCT07776405University of FloridaA Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis | 2027-03-31 |
Among the 45 studies in Fasciitis, Plantar with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
The control group will receive a placebo cream identical in appearance, texture, scent, and packaging to the active product but containing no cannabidiol.
• Immediate pain relief, measured by change in numeric rating scale (0-10) from baseline to ten minutes after supervised application.
Time frame: Daily for one month
• One-month changes in average daily pain score compared to baseline.
Time frame: Daily for one month
• Global patient satisfaction
measured using a five-point Likert scale assessing overall perceived improvement.
Time frame: Daily for one month.
Duration of immediate pain relief following initial application
Time frame: Daily for one month
Adherence to protocol measured by patient logs and pump counts
Time frame: Daily for one month
Incidence of adverse effects
Occurrence of negative side effects
Time frame: Daily for one month
Rescue analgesic use
Time frame: Daily for one month
Time to perceived improvement in symptoms
Time frame: Daily for one month
6. PROMIS Pain Interference questionnaire
Time frame: At enrollment and at end of once month
7. Foot Function Index questionnaires
Time frame: 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
Time frame: Once during one month
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol