Diabetic Foot UlcersPhase 4MDTDFNCT02816749
Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Diabetic Foot Ulcers
A Phase 4 study testing Maggot debridement therapy and Conventional Dressing Therapy in people with Diabetic Foot Ulcers, run by The First Affiliated Hospital of Dalian Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Maggot debridement therapy and Conventional Dressing Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2016to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Enrolling by invitation
the Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
- Recruiting
the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Chengchun Qu, 86-0411-83635963 ext. 3015, quchengchun@126.com
Yinan Wang, 86-0411-83635963 ext. 3037, dyfyjwb@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Maggot debridement therapy, Conventional Dressing Therapy
- Keywords
- Diabetic Foot, Wound Healing, Larva, Occlusive Dressings
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maggot debridement therapyProcedure or surgery
Also called MDT, Maggot Therapy, Larvae Therapy
Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
Conventional Dressing TherapyProcedure or surgery
Also called CDT, Occlusive Dressings, Dressing Therapy
Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
| Study group | Role | What they receive |
|---|---|---|
| Maggot debridement therapy(MDT) | Experimental | Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed. Receives: Procedure: Maggot debridement therapy |
| Conventional Dressing Therapy(CDT) | Active comparator | Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed. Receives: Procedure: Conventional Dressing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time(days)
Wound complete closure is achieved.
Measured: 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)
Area of wounds are measured by transparency-based digital imaging method.Every 3/4 days when procedures(bio-bags/dressings) given.
Measured: 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.
Measured: 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.
Measured: From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shou-Yu Wang, Dr, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816749
- Sponsor's protocol ID
- DMUF-01
- Acronym
- MDTDF
- Status last verified
- Jun 2016
- First submitted
- 26 Apr 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25963495Sun 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.
PubMed 24841930Shi 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.
PubMed 25478859Sherman 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.
PubMed 17975368
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maggot Debridement Therapy Versus Conventional Dressing Therapy to Treat Type 2 Diabetic Mellitus Foot Ulcers: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02816749
- Acronym / sponsor ID
- MDTDF / DMUF-01
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetic Foot, Wound Healing, Larva, Occlusive Dressings
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maggot debridement therapy(MDT) | Experimental | Procedure: Maggot debridement therapyParticipant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed. |
| Conventional Dressing Therapy(CDT) | Active comparator | Procedure: Conventional Dressing TherapyParticipant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maggot debridement therapyAlso: MDT, Maggot Therapy, Larvae TherapyParticipant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed. | Procedure or surgery | Maggot debridement therapy(MDT) |
| Conventional Dressing TherapyAlso: CDT, Occlusive Dressings, Dressing TherapyParticipant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed. | Procedure or surgery | Conventional Dressing Therapy(CDT) |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Background: PubMed 25963495Pinheiro 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.
- Background: PubMed 24841930Sun 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.
- Background: PubMed 25478859Shi 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.
- Background: PubMed 17975368Sherman 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shou-Yu Wang, Dr principal investigator
The First Affiliated Hospital of Dalian Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maggot debridement therapy and Conventional Dressing Therapy in people with Diabetic Foot Ulcers, run by The First Affiliated Hospital of Dalian Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun-Wei Zong (8618098876071, aweizone@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816749, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.