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

Sponsor

National University of Malaysia (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05804890

Collaborator

Dyamed Biotech Sdn Bhd (Other)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
ZORFLEX Activated Carbon Cloth Dressing
AQUACEL Silver-Based Dressing

Outcome Measures

Primary Outcome Measures

Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18 or older
Able and willing to provide consent and agree to comply with study procedures and follow-up evaluations
Patients with type 1 or type 2 diabetes mellitus.
Wagner classification grade 1-3
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
Additional wounds may be present but not within 3cm of the study wound.
Serum creatinine <3.0 mg/dl (266.0umol/L)
Glycosylated haemoglobin (HbA1c) <12%
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Canselor Tuanku Muhriz UKM	Cheras	Wilayah Persekutuan Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

National University of Malaysia
Dyamed Biotech Sdn Bhd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

National University of Malaysia

ClinicalTrials.gov Identifier:

NCT05804890

Other Study ID Numbers:

FF-2022-294

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Ulcer

Study Results

No Results Posted as of Apr 7, 2023