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Nutritional Supplement on Wound Healing in Diabetic Foot

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ClinicalTrials.gov Identifier: NCT03679273
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Diabetic foot ulcer (DFU) is the leading cause of non-traumatic limb loss in adult worldwide. One of the major causes of limb loss in patients with DFU is poor wound healing. It is known that nutrition plays a key role in wound healing, not only because of the required calories, but more importantly for collagen remodeling by specific amino acids (arginine, glutamine, and β-hydroxy-β-methylbutyrate).

Nevertheless, few studies have investigated nutritional supplements in patients with poor wound healing of DFU. Difficulties in assessing the severity of a wound and poor adherence to drug and food supplements at home may be important factors for the negative results shown in a most recent prospective randomized controlled trial. The diabetic foot center in Chang Gung Memorial hospital has extensive experience in caring for patients with limb-threatening DFU and we recently reported that poor nutritional status in our patients correlated to poor treatment outcomes. The aim of this study is to evaluate the clinical efficacy and possible molecular mechanisms in nutritional treatment for limb-threatening DFU. A total of 70 patients will be enrolled and randomized into study and control groups. All subjects will receive standard care. Additional amino acid supplements containing arginine, glutamine, and β-hydroxy-β-methylbutyrate or a control (high protein formula powder) will be given orally twice a day for 21 days, and the percentage change in wound size will then be measured. Complete healing time, recurrence or major adverse cardiac events will be recorded during one year of follow up. Data on wound size, nutritional status, and levels of matrix metallopeptidase (MMP)-2, MMP-9, nutrient molecules (measured by ABSOLUTE/DQ P180 KIT (LC MS/MS) will be recorded before and after the nutritional supplementation. In addition, the pioneer factor forkhead box protein A2 (FOXA2) that binds native chromatin and bookmarks genomic regions for transcriptional activity may play a role in nutritional supplements in acute stressed diabetic patients. Therefore, we intend to conduct a pilot study on the for FOXA2 gene in maintaining glucose homeostasis in diabetic foot patients after nutritional interventions.


Condition or disease Intervention/treatment Phase
Diabetic Foot Dietary Supplement: Abound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness and Molecular Mechanisms of Nutritional Supplement on Wound Healing in Diabetic Patients With Limb-threatening Foot Ulcer
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abound supplement
The participant will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days.
Dietary Supplement: Abound
Study Group will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days.

No Intervention: Traditional supplement
The participant will take traditional diabetes-specific formula as provided by dietitians.



Primary Outcome Measures :
  1. PEDIS score [ Time Frame: one year ]
    Measurement of wound size change



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects will be considered for entry if they are men or non-pregnant women, aged ≥ 40 years or ≤ 80 years
  2. a serum albumin level between 2.0 mg/dL and 4.0 mg/dL, had peripheral occlusive arterial disease with an ankle-brachial index (ABI) ≤0.9 or Doppler arterial waveforms that are biphasic or monophasic
  3. a serum C-reactive protein level ≤ 50 mg/L .

Exclusion Criteria:

Subjects will be excluded from the study if they have serious comorbidities such as

  1. pneumonia,
  2. active malignancy, severe renal function impairment (creatinine < 3 mg/dl), heart failure (NYHA Fc ≥ 3),
  3. liver failure/cirrhosis (Child class B or C),
  4. myocardial infarction in the past 3 months,
  5. wounds complicated with persistent osteomyelitis,
  6. a Charcot deformity,
  7. alcohol/substance abuse,
  8. any mental or physiological condition that may interfere with dietary intake,
  9. history of allergy to any of the ingredients in the supplement,
  10. those who are unable to follow orders or cooperate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679273


Contacts
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Contact: Yu-Yao Huang, MD, PhD +886-3-3281200 ext 8826 yyh@cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 333
Contact: Yu-Yao Huang    +88633281200 ext 8826    yyh@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03679273    
Other Study ID Numbers: 104-9965A3
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies