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

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ClinicalTrials.gov Identifier: NCT02816749
Recruitment Status : Unknown
Verified June 2016 by The First Affiliated Hospital of Dalian Medical University.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Dalian Medical University

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Procedure: Maggot debridement therapy Procedure: Conventional Dressing Therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Type 2 Diabetic Mellitus Foot Ulcers: A Prospective Randomized Controlled Study
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816749


Contacts
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Contact: Jun-Wei Zong 8618098876071 aweizone@163.com
Contact: Shou-Yu Wang, Dr 86041186110147 wangshouyu666@126.com

Locations
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China, Liaoning
the Second Affiliated Hospital of Dalian Medical University Enrolling by invitation
Dalian, Liaoning, China, 116000
the First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
Contact: Chengchun Qu    86-0411-83635963 ext 3015    quchengchun@126.com   
Contact: Yinan Wang    86-0411-83635963 ext 3037    dyfyjwb@163.com   
Sub-Investigator: Donghua Ji, Dr         
Sub-Investigator: Zhen Zhang, Dr         
Sub-Investigator: Junwei Zong         
Sub-Investigator: Linan Li, Dr         
Sub-Investigator: Hua Zhong         
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Investigators
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Principal Investigator: Shou-Yu Wang, Dr The First Affiliated Hospital of Dalian Medical University
Publications:
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Responsible Party: The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT02816749    
Other Study ID Numbers: DMUF-01
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The First Affiliated Hospital of Dalian Medical University:
Diabetic Foot
Wound Healing
Larva
Occlusive Dressings
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases