Pressure UlcersPhase 3MAGGOTNCT01211236
Maggot Therapy for Wound Debridement
A Phase 3 study testing application of wound dressing made of bio-bags (vitapads) containing maggots and application of classical hydrogel/alginate wound dressing in people with Pressure Ulcers, run by University Hospital, Caen at 3 sites in France.
Trial summary
The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- application of wound dressing made of bio-bags (vitapads) containing maggots and application of classical hydrogel/alginate wound dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2006to not given
- Phase
- Phase 3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient between 18 and 90 years old
- patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers
- pressure ulcers were less than 2cm-deep
- limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8
- signed informed consent
Who cannot join
- patients pregnant or lactating
- patients with neuropathy
- patients perforant ulcer of the foot
- patients with dementia
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hospital of Caen, dermatology department
Caen, Calvados, 14000
Robert Bisson Hospital
Lisieux, Calvados, 14107
Hopital des armées Desgenettes
Lyon, Rhone, 69000
About this study
Official title: Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.
- Conditions
- Pressure Ulcers
- Being tested
- application of wound dressing made of bio-bags (vitapads) containing maggots, application of classical hydrogel/alginate wound dressing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of wound dressing made of bio-bags (vitapads) containing maggotsOther
application of classical hydrogel/alginate wound dressingOther
| Study group | Role | What they receive |
|---|---|---|
| Maggot Debridement Therapy | Experimental | Not described Receives: Other: application of wound dressing made of bio-bags (vitapads) containing maggots |
| control | Active comparator | Not described Receives: Other: application of classical hydrogel/alginate wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Fibrin changes from day 0 to day 15
Secondary outcomes (1)
Percent of healing changes from day 0 to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211236
- Sponsor's protocol ID
- PHRC04-130
- Acronym
- MAGGOT
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Opletalova K, Blaizot X, Mourgeon B, Chene Y, Creveuil C, Combemale P, Laplaud AL, Sohyer-Lebreuilly I, Dompmartin A. Maggot therapy for wound debridement: a randomized multicenter trial. Arch Dermatol. 2012 Apr;148(4):432-8. doi: 10.1001/archdermatol.2011.1895. Epub 2011 Dec 19.
PubMed 22184720
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
- ClinicalTrials.gov ID
- NCT01211236
- Acronym / sponsor ID
- MAGGOT / PHRC04-130
- Conditions
- Pressure Ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Société de Dermatologie Française
- Study start
- Feb 2006
- First posted
- 29 Sep 2010 (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.
The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maggot Debridement Therapy | Experimental | Other: application of wound dressing made of bio-bags (vitapads) containing maggots |
| control | Active comparator | Other: application of classical hydrogel/alginate wound dressing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient between 18 and 90 years old
- patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers
- pressure ulcers were less than 2cm-deep
- limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8
- signed informed consent
Key exclusion criteria (4 listed)
- patients pregnant or lactating
- patients with neuropathy
- patients perforant ulcer of the foot
- patients with dementia
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 |
|---|---|---|
| application of wound dressing made of bio-bags (vitapads) containing maggots | Other | Maggot Debridement Therapy |
| application of classical hydrogel/alginate wound dressing | Other | control |
Primary outcome
Percent of Fibrin changes from day 0 to day 15
1 secondary outcome
Percent of healing changes from day 0 to day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
- Derived from this study: PubMed 22184720Opletalova K, Blaizot X, Mourgeon B, Chene Y, Creveuil C, Combemale P, Laplaud AL, Sohyer-Lebreuilly I, Dompmartin A. Maggot therapy for wound debridement: a randomized multicenter trial. Arch Dermatol. 2012 Apr;148(4):432-8. doi: 10.1001/archdermatol.2011.1895. Epub 2011 Dec 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing application of wound dressing made of bio-bags (vitapads) containing maggots and application of classical hydrogel/alginate wound dressing in people with Pressure Ulcers, run by University Hospital, Caen at 3 sites in France.
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 5 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: finished, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Fibrin changes from day 0 to day 15. 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 NCT01211236, which also lists 1 linked publication.
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 29 Sep 2010.