Health Condition 1: L974- Non-pressure chronic ulcer of heeland midfoot Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: STASITM Non-Absorbable Sponge: Haemostasis will be assessed at 5 and 10 minutes post-dressing, with treatment deemed successful if bleeding stops without additional measures within 10 m
Sponsors
Dr Rajat Engineer
Eligibility
Inclusion criteria
Inclusion criteria: - Adults male or female subjects aged 18 years and above with type I or II diabetes mellitus. - Ulcer classified as Wagner grade I or II ulcers (more than 2 cm in diameter size and less than 10cm, and a duration of more than 6 weeks). - Patients with good extremity circulation status, palpable pulse or confirmation with doppler sonography at the ankle (dorsalis pedis artery or posterior tibial artery). - Received anticoagulation therapy due to diabetic vasculopathy or systemic disease. - Patients with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening. - Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: - Hypersensitivity to STASITM Non-Absorbable Sponge or other components. - Pregnant or lactating women. - Patients undergoing Immunosuppressant therapy or systemic cardiopulmonary disease. - Refusal or inability to provide consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in each group achieving complete haemostasis at 10 minutes after dressing application, without the need for additional interventionsTimepoint: 10 mins after application | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients achieving complete haemostasis at 5 minutes - Percentage of patients experiencing complications defined as rebleeding of hematoma Timepoint: 5 min and 10 mins after application | — |
Countries
India
Contacts
Public ContactDr Rajat K Engineer
Shraddha Multispeciality Hopsital
Outcome results
None listed