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Diabetic Foot UlcerZORFLEXNCT05804890

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

An observational study of Diabetic Foot Ulcer, run by National University of Malaysia at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Foot Ulcer
How many people
40 participants
Where
1 siteMalaysia
Study dates
1 Aug 2022to 31 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

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.

Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05804890
Study groupRoleWhat they receive
ZORFLEXActivated Carbon Cloth Dressing
AQUACELSilver-Based Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start1 Aug 2022
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05804890
Sponsor's protocol ID
FF-2022-294
Acronym
ZORFLEX
Status last verified
Mar 2023
First submitted
7 Dec 2022
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Snyder RJ, Hanft JR. Diabetic foot ulcers--effects on QOL, costs, and mortality and the role of standard wound care and advanced-care therapies. Ostomy Wound Manage. 2009 Nov 1;55(11):28-38.

    PubMed 19934461

  • Shahbazian H, Yazdanpanah L, Latifi SM. Risk assessment of patients with diabetes for foot ulcers according to risk classification consensus of International Working Group on Diabetic Foot (IWGDF). Pak J Med Sci. 2013 May;29(3):730-4. doi: 10.12669/pjms.293.3473.

    PubMed 24353617

  • Aalaa M, Malazy OT, Sanjari M, Peimani M, Mohajeri-Tehrani M. Nurses' role in diabetic foot prevention and care; a review. J Diabetes Metab Disord. 2012 Nov 21;11(1):24. doi: 10.1186/2251-6581-11-24.

    PubMed 23497582

  • Iraj B, Khorvash F, Ebneshahidi A, Askari G. Prevention of diabetic foot ulcer. Int J Prev Med. 2013 Mar;4(3):373-6. No abstract available.

    PubMed 23626896

  • Fard AS, Esmaelzadeh M, Larijani B. Assessment and treatment of diabetic foot ulcer. Int J Clin Pract. 2007 Nov;61(11):1931-8. doi: 10.1111/j.1742-1241.2007.01534.x.

    PubMed 17935551

  • Leone S, Pascale R, Vitale M, Esposito S. [Epidemiology of diabetic foot]. Infez Med. 2012;20 Suppl 1:8-13. Italian.

    PubMed 22982692

  • Vileikyte L. Diabetic foot ulcers: a quality of life issue. Diabetes Metab Res Rev. 2001 Jul-Aug;17(4):246-9. doi: 10.1002/dmrr.216.

    PubMed 11544609

  • Murphy N. Reducing infection in chronic leg ulcers with an activated carbon cloth dressing. Br J Nurs. 2016 Jun 23;25(12):S38-44. doi: 10.12968/bjon.2016.25.12.S38.

    PubMed 27345081

  • Probst S, Saini C, Skinner MB. Comparison of sterile polyacrylate wound dressing with activated carbon cloth and a standard non-adhesive hydrocellular foam dressing with silver: a randomised controlled trial protocol. J Wound Care. 2019 Nov 2;28(11):722-728. doi: 10.12968/jowc.2019.28.11.722.

    PubMed 31721666

  • Scheer HS, Kaiser M, Zingg U. Results of directly applied activated carbon cloth in chronic wounds: a preliminary study. J Wound Care. 2017 Aug 2;26(8):476-481. doi: 10.12968/jowc.2017.26.8.476.

    PubMed 28795884

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot Ulcer, run by National University of Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05804890, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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