Diabetic Foot Ulcers Clinical Trial
Official title:
Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Type 2 Diabetic Mellitus Foot Ulcers: A Prospective Randomized Controlled Study
This is a prospective study of participants with diabetic foot ulcers who will receive either maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound healing time is the main outcome measure to compare the clinical efficacy of these two therapies. The investigators developed a hypothesis that MDT could achieve remarkable shorter time and better healing rate for wound closure when compared with CDT.
The investigators designed a prospective randomized study to compare the clinical safety and
efficacy of maggot debridement therapy (MDT) and conventional dressing therapy (CDT). This
study is scheduled from July 2016 to February 2017. Patients, aged from 18-80, who suffered
from type 2 diabetic mellitus foot ulcers with Grade 1 or Grade 2 according to the Wagner
classification could be the participants of this study. A sample of 138 participants was
calculated based on the morbidity of diabetic foot ulcers, accounting for estimated 10%
attrition rate. The glycemic control is important for the validity of study results. A
specific team of endocrine doctors will manage the blood glucose of participants of two
groups within the range of 7-10 mmol/L.
Participants will be allocated into MDT group and CDT group randomly according to the random
number table. For MDT-participants, bio-bags containing sterilized, live, medicinal Lucilia
sericata larvae will be placed on the wound of ulcers. For CDT-participants, conventional
dressing (disinfected by iodophor, dressed by gauze ) will be performed ordinally. Every 3
days the procedures of two groups will be performed and wounds assessment will be done until
the wounds closure is achieved. The wounds assessment, including measurement of the area of
wound surface and bacterial culture, will be performed by a specific team of microsurgical
doctors. The outcome measures include wound healing time (days) and the time negative
bacterial culture occurs (days). The secondary outcome measures include the area of wound
surface (cm2), treatment related pain, comfort of the dressing and adverse events.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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