Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population (ZORFLEX)

March 27, 2023 updated by: National University of Malaysia
One of the common complications of diabetes mellitus (DM) is Diabetic Foot Ulcer (DFU), which can subsequently lead to infections, gangrene, amputation or even death, if necessary care is not taken to curb with the condition. Despite the rapid advancements in the medical industry, diabetic foot ulcer (DFU) is considered as a major factor of morbidity and a leading cause of hospitalizations among diabetic patients. The risk of ulcer progression that may ultimately lead to amputation is elevated upon the development of DFU. It is estimated that DFU contributes approximately 50-70% of all lower limb amputations. In addition to rendering emotional and physical distress, DFU is also responsible for causing productivity and financial losses that lower the quality of life. The economic burden of the patients is further aggravated by the medical expenditure involved in the healing of DFU and/or lower extremity amputation. This study focuses on usage of a modern primary wound dressing in managing diabetic foot ulcer. The primary dressing used in this study is an activated carbon cloth dressing, which is applied directly to the wound bed and the "holes" in the net give access to the activated carbon which is made up of millions of micropores and within the walls of these micro pores, there is presence of electrostatic forces known as Van der Waals forces, which helps to trap and kill microorganisms such as MRSA and Pseudomonas aeruginosa. In addition, the dressings can regulate matrix metalloproteinases (MMPs) which are responsible for prolonged inflammation in chronic wounds like diabetic foot ulcers, and able to promote fibroblast migration and accelerate granulation tissue growth via its conductivity.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
        • Hospital Canselor Tuanku Muhriz UKM

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Malaysian population diagnosed with diabetes mellitus type 2 with diabetic foot ulcer.

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Able and willing to provide consent and agree to comply with study procedures and follow-up evaluations
  3. Patients with type 1 or type 2 diabetes mellitus.
  4. Wagner classification grade 1-3
  5. Patient's ulcer must be diabetic in origin. Debridement will be done prior to randomization.Ulcer size >1 and <25cm² ; ulcer duration of > 1 weeks
  6. Additional wounds may be present but not within 3cm of the study wound.
  7. Serum creatinine <3.0 mg/dl (266.0umol/L)
  8. Glycosylated haemoglobin (HbA1c) <12%
  9. Adequate circulation to the affected extremity as demonstrated by dorsum transcutaneousoxygen test (TcPO2) ≥ 30mmHg,ankle-brachial systolic index (ABSI) between 0.7 and 1.2 ortriphasic or biphasic Doppler arterial waveforms at the ankle of affected leg

Exclusion Criteria:

  1. Unconfirmed Diabetes Mellitus diagnosis.
  2. Wagner classification grade 4 and above.
  3. Patients whose index diabetic foot ulcers are greater than 25cm² .
  4. Patients considered not in reasonable metabolic control, confirmed by an HbA1c ≥ 12%within previous 90 days.
  5. Patients whose serum creatinine levels are 3.0mg/dl or greater.
  6. Patients with a known history of poor compliance with medical treatments.
  7. Patients who have been previously randomized into this study, or are presentlyparticipating in another clinical trial.
  8. Patients who are currently receiving radiation therapy or chemotherapy.
  9. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
  10. Patients diagnosed with autoimmune connective tissues diseases.
  11. Non-revascularizable surgical sites.
  12. Any other pathology that would limit the blood supply and compromise healing
  13. Patient who are pregnant or breast feeding.
  14. Refusal to give informed consent

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

Cohorts and Interventions

Group / Cohort
ZORFLEX
Activated Carbon Cloth Dressing
AQUACEL
Silver-Based Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population.
Time Frame: 6 months
The outcome measure is based on wound size in a span of 8 weeks. We used the same measurement tool for every patient's wound. The physiological parameters we use are FBC and CRP count. The questionnaires used was SF36.
6 months

Collaborators and Investigators

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

Sponsor

National University of Malaysia

Collaborators

Dyamed Biotech Sdn Bhd

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

Helpful Links

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 (Actual)

August 1, 2022

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2022-294

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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