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Metabolomics and Wound Healing in Diabetes

NCT04475861 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-07-17

No results posted yet for this study

Summary

The dysfunction of wound healing in diabetes involves multiple healing processes by diminished inflammatory responses and delayed deposition of matrix components, wound remodeling, and closure. Furthermore, hyperglycemia increases the infection susceptibility of wounds. In Taiwan, we have data demonstrating the nutrition status associated the outcome of diabetic foot ulcer (DFU) acute treatment and value of serum arginine level (in preliminary metabolomics study) to predict one-year healing of DFUs. The arginine has the beneficial effects on wound healing by the action of its metabolites, including vasodilatation, bactericide, growth factors recruitment and collage formation. Nevertheless, its supplement and mechanism in patients with diabetes is still remains unproven. This study aims at (1) defining the effects of arginine supplement, on top of the traditional treatment and risk reduction, on healing outcomes of patients with DFUs, (2) studying the modes of action of arginine supplements in diabetes, and (3) verifying the metabolomics factors and their association with wound healing prospects in patients with DFUs. A total of 120 patients with chronic diabetic foot ulcer will be enrolled and survey in 3 years. Along with standard of care, patients will receive, in a randomized fashion, either arginine (treatment group) or whey protein (control group) 5 g per day supplement for 4 weeks. The wound status will be collected with features in wound size, tissue perfusion, and infection status before and after treatment. Nutritional surveys, nitrogen balance as well as various molecular studies such as metabolomics analysis and neutrophil-to-lymphocyte ratio will be performed to study the association between the molecules of nutrients and the healing

Conditions

Interventions

DIETARY_SUPPLEMENT

L-arginine supplements and nutritional supports

The enrolled subjects will then be randomized into two groups. The subjects will receive either L-arginine (the study group) or another amino acid supplement (the control group), with 60 patients in each group. All the food intake of the subjects during the 4 weeks of the study will be recorded and supervised by responsible dietitians.

Sponsors & Collaborators

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2018-12-01
Completion
2025-06-18

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT04475861 on ClinicalTrials.gov