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Biofilm Study in Diabetic Foot Ulcer

Detection of Biofilm in diabetic foot ulcer and comparison of two dressing materials-Cadexomer Iodine and Nano silver ointment in its treatment

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037615
Enrollment
260
Registered
2021-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Control Intervention1: Cadexomer Iodine: We will do dressing with Cadexomer iodine ointment. The amount of ointment depends upon the size of the ulcer. Amount will be such as to cover the floor of the

Sponsors

GMERS Medical college Valsad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient of type-2 DM 2.Patient having ulcer on foot for more than 4 weeks. 3.Patient who is ready to give consent & cooperative. 4. Patient should have palpable dorsalis pedis & post tibial artery. 5.Ulcers should be chronic i.e. of more than 4 weeks duration.

Exclusion criteria

Exclusion criteria: 1.Patient not ready to give consent. 2.Irregular in taking medicine. 3.Persistently High Blood Sugar(FBS > 200mg% and/or PP2BS > 280 mg%). 4.Serum Creatinine > 3mg/dl 5.Poor Nutritional Status (Serum Protein >6.5 gm ,Serum Albumin < 3gm and or hemoglobin < 7 mg).

Design outcomes

Primary

MeasureTime frame
To know the rate of occurrence of biofilm in diabetic foot ulcer and to know the effectiveness of Cadexomer iodine and nano silver ointment in healing of chronic Diabetic foot ulcer with biofilm.Timepoint: Each patient will be dressed twice weekly & will be assessed for 6 weeks.

Secondary

MeasureTime frame
To compare the effectiveness of Cadexomer Iodine & nano Silver ointment in treating biofilm.Timepoint: Wound will be assessed every week for clinical and microbiological assessment for 6 weeks.

Countries

India

Contacts

Public ContactDR JANAK N PAREKH

GMERS MEDICAL COLLEGE AND HOSPITAL VALSAD

janak.nvs@gmail.com9825130377

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026