Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy

NCT07162454 | Completed

• 1 other identifier: 24/193-EC_X
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of cannabidiol and urea 10%.

Conditions

Xerosis Cutis; Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Keywords

Diabetes mellitus; Diabetic foot; Diabetic neuropathy; Neuropathic pain; Cannabidiol; Urea 10%

Outcome Measures

Primary Outcomes (1)

• Assessment of neuropathic pain.

  Neuropathic pain was assessed using the validated neuropathic pain assessment scale.

  From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.

Secondary Outcomes (1)

• Skin quality assessment

  From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.

Study Arms (3)

Group 1. Complete formula.

EXPERIMENTAL

Participants in this group received a cream with cannabidiol, urea 10%, arnica and menthol as active ingredients during 1 month.

Drug: Group 1. Complete formula

Group 2. Cannabidiol and Urea 10% formula.

EXPERIMENTAL

Participants in this group received a cream with cannabidiol, urea 10% as active ingredients during 1 month.

Drug: Group 2. Cannabidiol and Urea 10% formula.

Group 3. Base formula.

PLACEBO COMPARATOR

Participants in this group received a base cream with no active ingredients.

Drug: Group 3. Placebo formula.

Interventions

Group 1. Complete formula DRUG

After fulfilling the criteria and agreeing to participate in the study, patients who were included in group 1 after randomisation were evaluated and received a topical cream with cannabidiol, Urea 10%, arnica and menthol as active ingredients. After one month of application of the formula, a second evaluation was carried out.

Group 1. Complete formula.

Group 2. Cannabidiol and Urea 10% formula. DRUG

After meeting the criteria and agreeing to participate in the study, the patients who were included in group 2 after randomisation were evaluated and received a topical cream containing cannabidiol and 10% urea. After one month of application of the formula, a second evaluation was carried out.

Group 2. Cannabidiol and Urea 10% formula.

Group 3. Placebo formula. DRUG

Participants included in this group after randomisation received a formulation with no active ingredients included in its composition and were assessed at baseline and after one month.

Group 3. Base formula.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients all biological sexes
• Patients of legal age (18 years).
• Patients without cognitive impairment
• Patients Diagnosed with diabetic neuropathy,
• Patients who were able to complete the neuropathic pain scale autonomously, cooperatively and independently.

You may not qualify if:

• Patients who declined participation
• Patients with critical ischaemia and
• Patients with a history of allergy or hypersensitivity to any of the components of the cream were excluded from the study.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Facultad de Enfermería, Fisioterapia y Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Related Publications (1)

• Xu DH, Cullen BD, Tang M, Fang Y. The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities. Curr Pharm Biotechnol. 2020;21(5):390-402. doi: 10.2174/1389201020666191202111534.

  PMID: 31793418 BACKGROUND

Related Links

• Research background on the effect of topical cannabidiol on various neuropathies.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Diabetic Neuropathies; Neuralgia

Interventions

Urea; Food, Formulated

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• José Luis Lázaro Martinez, Podiatrist

  Clínica Universitaria de podología de la Universidad Complutense de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Podiatrist. Specialist in diabetic foot.

Model Details: Three groups were created and each group was assigned a different composition. A baseline and a final evaluation was performed after one month to assess the neuropathic pain and skin quality of the participants.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: November 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)