Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

January 11, 2021 updated by: MSSAMIR, Assiut University
Diabetic foot ulcer is the commonest cause of severe limb ischemia in diabetes mellitus And development of anemia is an additional burden to the microvascular complications of diabetes

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

HBA1C is the predominant Hemoglobin found in HBA1 fraction and it constitutes 5% of total Hemoglobin in normal adults and up to 15%in patients with diabetes mellitus HBA1C is used to diagnose diabetes and to identify individuals that are at high risk for developing diabetes Iron deficiency anemia is one of the most prevalent form of malnutrition affect 1,62 billion people whish correspond to 24,8%of the world population Ferritin is the storage form of iron so it is found to be test for distinguishing those with iron deficiency anemia from those who are not iron deficient

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients with diabetic foot ulcer grade one and two with or without iron deficiency anemia

Description

Inclusion Criteria:

  • all diabetic patients with diabetic foot ulcer grade one and two above 18 year

Exclusion Criteria:

  1. patients with anemia other than iron deficiency anemia
  2. Patients on anticoagulants
  3. patients with blood disease 4-patients below 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetic foot ulcer (1and2)with iron defic

50 diabetic patients with diabetic foot ulcer grade (1and2) with iron deficiency anemia will be applied TO

  1. cbc
  2. ferritin
  3. HBA1C
  4. ankle brachial index by duplex
Diagnostic test: CBC ,Serum ferritin ,HBA1C
Diabetic patients will be applied to CBC, HBA1C and serum ferritin
Other Names:
  • Ankle brachial index by duplex
diabetic foot ulcer grade(1and2)without iron deficiency anemia

50 patients with diabetic foot ulcer grade (1and2) without iron deficiency anemia will be applied to

  1. CBC
  2. Ferritin,
  3. HBA1C
  4. ankle brachial index by duplex
Diagnostic test: CBC ,Serum ferritin ,HBA1C
Diabetic patients will be applied to CBC, HBA1C and serum ferritin
Other Names:
  • Ankle brachial index by duplex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron deficiency detected by Hemoglobin level in g/dl HBA1C level in diabetic patients
Time Frame: Base line
The influence of iron deficiency anemia on HBA1C in diabetic patients
Base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBA1C and anemia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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