Table 1 Study time-period

Enrolment

Allocation

Post-allocation

Close-out

TIMEPOINT

-1 day

0 day

After 14 days

After 28 days

ENROLLMENT:

  Eligibility screen

●

  Informed consent

●

  Allocation

●

INTERVENTIONS:

  Treatment group: Shengji ointment and Pineapple protease (bromelain)

●

●

●

  Control group: Comfeel® Plus wound dressing

●

●

●

ASSESSMENTS:

  Demographic data

●

  Medical history and allergy history

●

  Vital signs

●

●

●

  Physical examination

●

●

●

  Blood routine + C- reactive protein

●

●

  Urine routine

●

●

  Routine stool + occult blood

●

●

  Liver function

●

●

  Renal function

●

●

  Electrocardiogram

●

●

  Urine pregnancy test

●

  Wound coverage rate

●

●

●

  Wound healing rate

●

●

●

  Amputation extent

●

●

  Granulation time

●

●

  Maryland Foot Score

●

●

●

  Clearance time

●

●

  Granulation tissue score

●

●

  Adverse events

●

●

●