Impact of customized nutritional package on Macro and Micro Nutrients (MAMN) in wound healing
- Conditions
- Health Condition 1: L89- Pressure ulcer
- Registration Number
- CTRI/2019/07/020355
- Lead Sponsor
- ICMR has technically approved
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
Adult patient ( >18 years) of both gender.
Patient should have wound with a size ranging from 3X3 cm to 15X15 cm (length X width).
The duration of the wound should be greater than 10 days.
Patient who can take food orally.
Patient/family members can read and write Kannada or English.
Pregnant women or post ?partum women within six weeks of delivery.
Uncontrolled diabetes (HbA1c >12%)
Diagnosed to have non healing ulcer with autoimmune disorder (e.g. systemic lupus erythematosus), immunosuppressed status (e.g. HIV), chronic wound for more than 2 years
Recent intake of systemic steroids
Patient on recombinant human platelet ?derived growth factor or similar therapies
Bioengineered tissue use within four weeks prior to baseline
Systemic antibiotic use within one week prior to enrolment
History of radiation treatment at the wound site
Wounds resulting from burns, venous insufficiency or osteomyelitis
Presence of co-morbidity such as active malignancy, renal function impairment (blood urea nitrogen < 21.4 mmol/l, creatinine < 247.5 umol/l), liver failure/cirrhosis (Child class B or C), any mental condition that may interfere with dietary intake;
Patient who is planned for skin graft at the time of enrollment
Critically ill patient requiring ICU care
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound healingTimepoint: Assessment will be done after 7 days and 30 days of interventions
- Secondary Outcome Measures
Name Time Method Biochemical ParametersTimepoint: 6 months