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To compare two different methods of dressing of wounds in the lower limb of diabetic patients following surgical debridement or amputation.

Negative pressure wound therapy (NPWT) using a portable vacuum assisted closure device in the management of post-surgical diabetic lower extremity wounds: a randomized control study. - MOBIVAC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029374
Enrollment
52
Registered
2020-11-25
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: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Mobivac: Negative pressure wound therapy using, Mobivac, a portable vacuum assisted closure device Control Intervention1: Normal Saline dressings: Moist wound therapy (Normal saline dre

Sponsors

Christian Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Type 2 Diabetic patient above 18 years of age with post-surgical lower extremity wounds, who have consented to be part of the study.

Exclusion criteria

Exclusion criteria: 1. Patients with bilateral involvement 2. Patients with peripheral vascular disease 3. Patients with coagulopathy 4. Patients suspected to have chronic venous insufficiency. 5. Patients with underlying osteomyelitis. 6. Patients with Charcotâ??s joint 7. Pregnant patients 8. Patients with Chronic kidney disease 9. Patients with Chronic liver disease 10. Patients with a malignancy 11. Patients with coronary artery disease

Design outcomes

Primary

MeasureTime frame
To compare the rate of reduction in size of the post-surgical lower extremity wounds in diabetic patients, undergoing dressings with Mobivac the vacuum assisted closure device and moist wound therapy (Normal saline dressings).Timepoint: To review patients wounds belonging to both arms of the study every week to assess the size of the wounds till they heal completely.—

Secondary

MeasureTime frame
1. To compare the time taken for the wounds to heal completely in patients in both arms. 2. To compare the time taken for the wounds to be covered by granulation tissue in patients in both arms. 3. Monitor the negative pressures daily from the wound surface in patients in the arm undergoing NPWT using MOBIVAC APP. 4. To compare the incidence and severity of pain, bleeding and infection in patients belonging to both arms Timepoint: Patients belonging to both arms of the study will be reviewed every week to assess the above parameters till the wounds heal completely.—

Countries

India

Contacts

Public ContactDr Vasanth Mark Samuel

Christian Medical College, Vellore

sur1@cmcvellore.ac.in0416-2282082

Outcome results

None listed

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