Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Catalysis SL

Status and phase: Completed; Phase 2

Conditions: Diabetic Foot; Diabetes Mellitus, Type 2; Diabetic Foot Ulcer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: DIAMEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03583593

DIAMEL-DIABETICFOOT

Details and patient eligibility

About

Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.

Enrollment: 100 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population

Exclusion criteria

• Manifestation of hypersensitivity to any component of the product
• Uncooperative patients
• Severe infection
• Debilitating diseases
• Steroid treatment
• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

DIAMEL

Experimental group

Description:

Study group that receives the active product.

Treatment:

Dietary Supplement: DIAMEL

Placebo

Placebo Comparator group

Description:

Control group receiving double-blind placebo.

Treatment:

Dietary Supplement: Placebo