Topical Retinoids and Diabetic Neuropathic Ulceration - Retinoid Study

Phase 1

• Conditions: The overall goal of the proposal is to assess the capacity of topical retinoid treatment to induce changes in connective tissue metabolism (i.e., increased collagen production and decreased elaboration of matrix metalloproteinases [MMPs]) in the skin of diabetic patients.; MedDRA version: 9.1 Level: LLT Classification code 10050712 Term: Vitamin A

• Registration Number: EUCTR2006-005597-43-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-14
• Study Completion: 2013-03-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Type 1 or Type 2 Diabetes as defined by the World Health Organisation classification.
2.Age between 18-70 years.
3.Women of child bearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
4.Must meet the specified criteria for diabetic neuropathy and have no risk factors for other causes of neuropathy
5.Willingness to sign the Centre for Research Ethics Committee (COREC) approved informed consent form.
6.The presence of microalbuminurea and/or retinopathy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Nursing mothers, pregnant women (excluded by a negative pregnancy test).
2.Patients with a history of drug or alcohol dependence within the last 5 years.
3.Patients with severe systemic disease other than diabetes which has a recognized complication of neuropathy.
4.Patients with a history of previous kidney, pancreas or cardiac transplantation.
5.Serious or unstable medical or psychological state that may interfere with study participation.
6.Patients having taken part in another investigational drug study within the last three months.
7.Patients who refuse to sign the informed consent form.
8.Patients with pre-existing generalized skin conditions which might affect skin structure or function such as eczema, psoriasis.
9.Patients who are on long term steroid or immunosuppressive therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified