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

Diabetic Foot Ulcer Clinical Trial

— ZORFLEX  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05804890
• Other study ID #: FF-2022-294
• Status: Enrolling by invitation
• Start date: August 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Locations

Country	Name	City	State
Malaysia	Hospital Canselor Tuanku Muhriz UKM	Cheras	Wilayah Persekutuan Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
National University of Malaysia	Dyamed Biotech Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months

External Links

•   An Evaluation of the Zorflex Carbon Fibre Dressing Poster
•   Zorflex. 2017; https://tinyurl.com/yaoapvj8 (accessed 25 July 2017)