Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Type 2 Diabetic Mellitus Foot Ulcers: A Prospective Randomized Controlled Study

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Procedure: Maggot debridement therapy
* Procedure: Conventional Dressing Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged from 18-80 years old. Participants with type 2 diabetes mellitus longer than one year, foot ulcer longer than three weeks and with ischemic symptoms of lower limb. The ulcer erosion depth is not reached and muscle layer. The Wagner classification of ulcers should be Grade 1 or Grade 2. Blood glucose control: Fasting blood glucose ≤ 8mmol / L; Postprandial blood glucose two hours ≤ 11.1 mmol / L. Participants do not receive ulcer wound management in the past three days when recruited. Participants with neuropathy symptoms, such as limb numbness, tingling or pain, especially pain at night. Exclusion Criteria: Participants with acute thrombosis that required thrombolysis or thrombectomy. Participants with severe systemic infection. Participants who are sensitive to pain. Participants with bone/joint deformities of foot (eagle claw toes, hammer toes)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maggot debridement therapy(MDT)<br>Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed. | Procedure: Maggot debridement therapy<br>* Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.<br>* Other names: Larvae Therapy;|
| Active Comparator: Conventional Dressing Therapy(CDT)<br>Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed. | Procedure: Conventional Dressing Therapy<br>* Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.<br>* Other names: Dressing Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing time(days) | Wound complete closure is achieved. | From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot, Wound Healing, Larva, Occlusive Dressings