Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-06-30

Brief Summary

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Evaluation of cannabidiol and urea 10%.

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Detailed Description

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This study evaluated the impact of cannabidiol on neuropathic pain and the action of urea 10% on skin quality in patients with diabetic foot syndrome and diabetic neuropathy.

Conditions

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Xerosis Cutis Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1. Complete formula.

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

Group Type EXPERIMENTAL

Group 1. Complete formula

Intervention Type 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 2. Cannabidiol and Urea 10% formula.

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

Group Type EXPERIMENTAL

Group 2. Cannabidiol and Urea 10% formula.

Intervention Type 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 3. Base formula.

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

Group Type PLACEBO_COMPARATOR

Group 3. Placebo formula.

Intervention Type 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.

Interventions

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Group 1. Complete formula

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.

Intervention Type DRUG

Group 2. Cannabidiol and Urea 10% formula.

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.

Intervention Type DRUG

Group 3. Placebo formula.

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No