Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Diabetic Foot Ulcers
MDTDF
1 other identifier
interventional
138
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2016
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJuly 1, 2016
June 1, 2016
6 months
April 26, 2016
June 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Area of wounds (cm2)
From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Adverse events
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)
From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Study Arms (2)
Maggot debridement therapy(MDT)
EXPERIMENTALParticipant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Conventional Dressing Therapy(CDT)
ACTIVE COMPARATORParticipant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Interventions
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
the Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Related Publications (4)
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.
PMID: 25963495BACKGROUNDSun 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.
PMID: 24841930BACKGROUNDShi 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.
PMID: 25478859BACKGROUNDSherman 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.
PMID: 17975368BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shou-Yu Wang, Dr
The First Affiliated Hospital of Dalian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
June 29, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
July 1, 2016
Record last verified: 2016-06