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Assessment of the Clinical, Cellular and Molecular Effects of Royalactin-Royal Jelly on the Healing of Wagner Grad II Diabetic Foot Ulcers.

NCT07509268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-03

No results posted yet for this study

Summary

The aim of this study is to evaluate the clinical, cellular, and molecular effects of Royalactin as an adjunct to standard treatment, compared to standard treatment alone, in the treatment of Wagner grade II diabetic foot ulcers by assessing wound size, cell behavior (Epithelialization, polymorphonuclear neutrophils, fibroblasts, angiogenesis, and collagen), and growth factor expression. This is a prospective, randomized, double-blind, double-blind, experimental, longitudinal, comparative, controlled clinical trial.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Royalactina

Standardized wound care is performed 3 times a week with application of Royalactin for 4 weeks

DRUG

Placebo

Standardized wound care is performed 3 times a week with placebo application for 4 weeks

Sponsors & Collaborators

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Jose L Elizondo, cirujano general · Sin afiliacion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2025-09-30
Completion
2025-10-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07509268 on ClinicalTrials.gov