Metabolomics and Wound Healing in Diabetes

NCT04475861 | Withdrawn

• 1 other identifier: 201702332A3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus, Type 2; Infection

Outcome Measures

Primary Outcomes (1)

• PEDIS

  Wound assessment was recorded using the PEDIS system

  up to 1 months

Study Arms (2)

L-arginine supplements

EXPERIMENTAL

The enrolled subjects will then be randomized into two groups. Study Group: will take a supplementation pill containing 5 g L-arginine (0.5g/ pill, GNC, USA) All the food intake of the subjects during the 4 weeks of the study will be recorded and supervised by responsible dietitians.

Dietary Supplement: L-arginine supplements and nutritional supports

nutritional supports

NO INTERVENTION

The enrolled subjects will then be randomized into two groups. Control group: will take a supplementation pill containing 5 g whey protein (5g/ pack, Santosa,Taiwan). All the food intake of the subjects during the 4 weeks of the study will be recorded and supervised by responsible dietitians.

Interventions

L-arginine supplements and nutritional supports DIETARY_SUPPLEMENT

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.

L-arginine supplements

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are men or non-pregnant women, aged ≥ 40 years or ≤ 80 years
• have a history of foot ulcers for more than 1 month
• have a serum albumin level ≤ 4.0 or an ABI level ≤ 1

You may not qualify if:

• Have active malignancy
• Have acute gastrointestinal surgery
• are receiving dialysis
• have heart failure (NYHA Fc ≥ 3), liver cirrhosis (Child class \> B), or myocardial infarction in the past 3 months,
• have wounds complicated with persistent osteomyelitis or Charcot deformity
• are receiving hydroxyurea or steroid treatment
• have alcohol abuse, any mental or physiological condition that may interfere with dietary intake, and those who are unable to follow orders or cooperate.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 333, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Infections

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: July 17, 2020
• Study Start: October 31, 2018
• Primary Completion: December 1, 2018
• Study Completion: June 18, 2025
• Last Updated: July 17, 2020

Record last verified: 2018-06

Locations

TW (1)