Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Diabetic Foot Ulcers (MDTDF)

June 30, 2016 updated by: The First Affiliated Hospital of Dalian Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Sub-Investigator:
          • Donghua Ji, Dr
        • Sub-Investigator:
          • Zhen Zhang, Dr
        • Sub-Investigator:
          • Junwei Zong
        • Sub-Investigator:
          • Linan Li, Dr
        • Sub-Investigator:
          • Hua Zhong
      • Dalian, Liaoning, China, 116000
        • Enrolling by invitation
        • The Second Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants aged from 18-80 years old.
  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:

  1. Participants with acute thrombosis that required thrombolysis or thrombectomy.
  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Shou-Yu Wang, Dr, The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMUF-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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