Clinical trial NCT05804890: Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population
Official title: Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcer
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Dyamed Biotech Sdn Bhd
First posted: 2023-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Malaysian population diagnosed with diabetes mellitus type 2 with diabetic foot ulcer.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparing Activated Carbon Cloth Dressing and Silver-Based Dressing in a Diabetic Foot Ulcer Population.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz UKM
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References:
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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.
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