Diabetic Foot Ulcer Clinical Trial
Official title:
Evaluating the Effectiveness of Collagen Matrix Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients: a Randomised Control Trial
Verified date | October 2022 |
Source | Corporacion Parc Tauli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU. This is a double-blinded, randomised clinical trial.
Status | Completed |
Enrollment | 180 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: - patients with neuropathic DFUs at Grades I or II for a period of at least 12 weeks, based on the Wagner classification; - be able to understand simple instructions and provided voluntary, signed informed consent. Exclusion Criteria: - active infection which might lead to hospitalisation, gangrene, - systemic inflammatory or autoimmune disease - renal failure - presence of ischaemia or osteomyelitis |
Country | Name | City | State |
---|---|---|---|
Pakistan | Zainab Khan | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in DFU size | change in DFU size using the manual planimetric method | 3 months | |
Secondary | Complete wound healing | Complete wound healing using three-dimensional wound measurement software | 3 months |
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