Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Diabetic Foot Ulcers
NCT ID: NCT02816749
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
138 participants
INTERVENTIONAL
2016-06-30
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maggot debridement therapy(MDT)
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Maggot debridement therapy
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Conventional Dressing Therapy(CDT)
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Conventional Dressing Therapy
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Interventions
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Maggot debridement therapy
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Conventional Dressing Therapy
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with type 2 diabetes mellitus longer than one year, foot ulcer longer than three weeks and with ischemic symptoms of lower limb.
3. The ulcer erosion depth is not reached and muscle layer.
4. The Wagner classification of ulcers should be Grade 1 or Grade 2.
5. Blood glucose control: Fasting blood glucose ≤ 8mmol / L; Postprandial blood glucose two hours ≤ 11.1 mmol / L.
6. Participants do not receive ulcer wound management in the past three days when recruited.
7. Participants with neuropathy symptoms, such as limb numbness, tingling or pain, especially pain at night.
Exclusion Criteria
2. Participants with severe systemic infection.
3. Participants who are sensitive to pain.
4. Participants with bone/joint deformities of foot (eagle claw toes, hammer toes)
18 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
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Principal Investigators
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Shou-Yu Wang, Dr
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
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the Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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References
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Pinheiro MA, Ferraz JB, Junior MA, Moura AD, da Costa ME, Costa FJ, Neto VF, Neto RM, Gama RA. Use of maggot therapy for treating a diabetic foot ulcer colonized by multidrug resistant bacteria in Brazil. Indian J Med Res. 2015 Mar;141(3):340-2. doi: 10.4103/0971-5916.156628.
Sun X, Jiang K, Chen J, Wu L, Lu H, Wang A, Wang J. A systematic review of maggot debridement therapy for chronically infected wounds and ulcers. Int J Infect Dis. 2014 Aug;25:32-7. doi: 10.1016/j.ijid.2014.03.1397. Epub 2014 May 16.
Shi E, Shofler D. Maggot debridement therapy: a systematic review. Br J Community Nurs. 2014 Dec;Suppl Wound Care:S6-13. doi: 10.12968/bjcn.2014.19.Sup12.S6.
Sherman RA, Shapiro CE, Yang RM. Maggot therapy for problematic wounds: uncommon and off-label applications. Adv Skin Wound Care. 2007 Nov;20(11):602-10. doi: 10.1097/01.ASW.0000284943.70825.a8.
Other Identifiers
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DMUF-01
Identifier Type: -
Identifier Source: org_study_id
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