A Phase 4 interventional study of Maggot debridement therapy and Conventional Dressing Therapy in Diabetic Foot Ulcers, sponsored by The First Affiliated Hospital of Dalian Medical University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-01.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Phase 4, Interventional, and Treatment
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.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's planned enrollment of 138 is above the median of 60 across 845 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Procedure: Maggot debridement therapy
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Procedure: Conventional Dressing Therapy
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Also known as: MDT, Maggot Therapy, Larvae Therapy
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Also known as: CDT, Occlusive Dressings, Dressing Therapy
Wound healing time(days)
Wound complete closure is achieved.
Time frame: From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Area of wounds (cm2)
Area of wounds are measured by transparency-based digital imaging method.Every 3/4 days when procedures(bio-bags/dressings) given.
Time frame: From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Adverse events
Adverse events such as allergic reaction, infection, local pain and escape of the larvae from bio-bag.Every 3/4 day when procedures(bio-bags/dressings) given.
Time frame: From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Negative bacterial culture time (days)
The time that negative bacterial culture occured from recruitment.
Time frame: From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Plan to share: Undecided
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Dalian Medical University