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A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6 months in both cohorts by a study staff member blinded to the randomization process.
The completed questionnaires were reviewed by a study staff member.
Once enrolled, a baseline questionnaire is administered in a private room by a study staff member.
Medication washout will be supervised by a study staff based on previously described safety protocols [ 5] after providing and instructing each subject on how to use a home sphygmomanometer.
In addition, exercise training sessions will be directly supervised (one-on-one) by a study staff member with an ACSM and/or personal trainer certification or who has been trained by a certified staff member on the study protocol.
Subsequent doses of the study medication (parecoxib 20 mg or placebo) were administered by a study staff nurse every 12 hours (±1 h) until postoperative day 2 (48 ± 1 h) after skin closure.
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Initial screening will be conducted by phone and will be repeated in person by a trained study staff at the enrolment session.
All participants met with a certified diabetes educator each month to track medication and health history changes, and all exercise sessions were constantly monitored by a trained study staff.
The primary outcome was rate of reduction in PU surface area (cm/day), judged by an external study staff member blinded to facility allocation who was trained in wound surface area measurement captured by digital photography.
Children at education group schools watched a 10 minute documentary style video and were given a booklet of cartoons, followed by a classroom discussion led by study staff.
Children who required hospitalization or tertiary-level care were transferred to a hospital by study staff.
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