Xerosis CutisNCT07162454
Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy
A study testing Group 1. Complete formula and Group 2. Cannabidiol and Urea 10% formula. in people with Xerosis Cutis and Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Evaluation of cannabidiol and urea 10%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerosis Cutis, Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- What is being tested?
- Group 1. Complete formula and Group 2. Cannabidiol and Urea 10% formula.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermería, Fisioterapia y Podología de la Universidad Complutense de Madrid
Madrid, 28040
About this study
Official title: A Triple-Blind Randomised Clinical Trial on the Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy
Evaluation of cannabidiol and urea 10%.
Read the detailed description
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.
- Being tested
- Group 1. Complete formula, Group 2. Cannabidiol and Urea 10% formula., Group 3. Placebo formula.
- Keywords
- Diabetes mellitus, Diabetic foot, Diabetic neuropathy, Neuropathic pain, Cannabidiol, Urea 10%
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Diabetic Neuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1. Complete formulaDrug
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.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. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Group 3. Placebo formula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of neuropathic pain.
Neuropathic pain was assessed using the validated neuropathic pain assessment scale.
Measured: 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
The assessment of skin quality was carried out using the validated questionnaire 'Injury Risk and Skin Quality Assessment Questionnaire'.
Measured: From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Nov 2024
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Sol Tejeda Ramírez, Universidad Complutense de Madrid
- Investigators
- José Luis Lázaro Martinez, Podiatrist, Study director, Clínica Universitaria de podología de la Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162454
- Sponsor's protocol ID
- 24/193-EC_X
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31793418
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-Blind Randomised Clinical Trial on the Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy
- ClinicalTrials.gov ID
- NCT07162454
- Acronym / sponsor ID
- 24/193-EC_X
- Keywords
- Diabetes mellitus, Diabetic foot, Diabetic neuropathy, Neuropathic pain, Cannabidiol, Urea 10%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of cannabidiol and urea 10%.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1. Complete formula. | Experimental | Drug: Group 1. Complete formulaParticipants in this group received a cream with cannabidiol, urea 10%, arnica and menthol as active ingredients during 1 month. |
| Group 2. Cannabidiol and Urea 10% formula. | Experimental | Drug: 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 3. Base formula. | Placebo comparator | Drug: Group 3. Placebo formula.Participants in this group received a base cream with no active ingredients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1. Complete formulaAfter 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. | Drug | Group 1. Complete formula. |
| 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. | Drug | Group 2. Cannabidiol and Urea 10% formula. |
| 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. | Drug | Group 3. Base formula. |
Primary outcome
Assessment of neuropathic pain.
Time frame: From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.
Neuropathic pain was assessed using the validated neuropathic pain assessment scale.
1 secondary outcome
Skin quality assessment
Time frame: From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 31793418Xu 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.
- Research background on the effect of topical cannabidiol on various neuropathies.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Lázaro Martinez, Podiatrist study director
Clínica Universitaria de podología de la Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1. Complete formula and Group 2. Cannabidiol and Urea 10% formula. in people with Xerosis Cutis and Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of neuropathic pain. (time frame: From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07162454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.