An interventional study of Larval Debridement Therapy and Bedside Sharp Debridement in Lower Extremity or Diabetic Foot Ulcers and Bacterial Infection, sponsored by North Florida Foundation for Research and Education. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by North Florida Foundation for Research and Education · Not applicable, Interventional, and Treatment
This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
Drug resistant organisms and bacterial biofilm pose an increasing threat to the health of millions of individuals world-wide. These organisms are being identified with an alarming prevalence among persons with chronic wounds. The presence of necrotic tissue has been associated with the deterioration of open wounds and serves as a breeding ground and nutrient source for bacteria. The removal of necrotic tissue is widely accepted as required for optimal wound healing.
The primary purpose of this study is to assess the efficacy of larval debridement therapy (LDT) with bagged, sterilized, live, medicinal blow fly (Lucilia sericata) larvae (or " BioBags") versus bedside sharp debridement in removing harmful bacteria, biofilm and necrotic tissue from chronic wounds to promote wound healing. Characteristics associated with chronic wound environments will be evaluated through analysis of samples of tissue taken from wound beds before and after both types of debridement. One hundred and forty patients ≥ 21 years of age (and their caregivers and wound providers)with an open, full thickness wound which is healing by secondary intention (of greater than 8 weeks duration and requires debridement) will be invited to participate. This recruitment number accounts for estimated 10% attrition rate, so final sample number is anticipated to be 296 or 128 Veteran subjects (64 in each arm) and 128 caregivers, and 6 providers (and total of 34 subjects which may be lost to follow up). Samples of wound bed tissue and slough tissue (if present) will be collected on Days 0, 4 and 8 or prior to and after each larval debridement intervention or sharp debridement (control). Photos will be taken of the wound bed on Days 0, 4 and 8 or just prior to and after each debridement method. A randomized sampling procedure will place individuals into one of two groups: The intervention group will receive larval debridement therapy once every 4 days for 2 applications (with saline moistened gauze as cover dressing changed daily) and the control group will receive sharp debridement therapy every 7 days for 2 debridements (with wound gel dressing changed daily).
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →North Florida Foundation for Research and Education is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Larval debridement therapy intervention (Biobags) filled with sterile green bottle fly maggots (larvae) placed in open, chronic lower extremity or diabetic foot ulcer once every 4 days for total of 2 applications over the 8 day study period.
Device: Larval Debridement Therapy
Bedside sharp debridement therapy as a comparator performed by wound care clinician once every 7 days in a chronic lower extremity or diabetic foot ulcer for a total of 2 sharp debridements over the 8 day study period.
Procedure: Bedside Sharp Debridement
small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm
Also known as: LDT, Maggot Debridement, MDT, Maggots, Medicinal Maggots, Larvae, Biobags
The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound
Also known as: Sharp debridement, Sharps
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Tryptic Soy Agar (TSA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
Time frame: Day 0 (Baseline), Day 4, Day 8
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with MacConkey Agar plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
Time frame: Day 0 (Baseline), Day 4, Day 8
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Phenylethyl Alcohol (PEA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
Time frame: Day 0 (Baseline), Day 4, Day 8
Reviewer Assessment of Visible Wound Improvement
For each patient, wound photos were taken at days 0, 4, and 8 and given to wound specialists. Wound specialists reviewed photos to assess whether there was visible reduction in amount of necrotic or non-viable tissue remaining in the wound bed at day 8--i.e., whether the wound appeared to be improved (yes vs. no). The percentage of reviewers (out of 4) who responded "yes" that the wound appeared improved was calculated for each patient. Thus, each patient received a score for percentage of reviewers who saw visual improvement; the means and standard deviations for these percentages were compared between LDT and SDT groups. Higher scores correspond to better outcomes (higher proportion of reviewers who responded that wounds appeared visibly improved).
Time frame: Day 8
Inflammatory Biomarker MMP-9
Using Enzyme Linked Immunosprbent Assay (ELISA), the levels of active Matrix Metalloproteinase type 9 (MMP-9) was calculated and expressed as pg/ml of wound fluid and pg/mg protein. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.
Time frame: Day 0 (Baseline), Day 4, Day 8
Inflammatory Biomarker IL6
The levels of active IL6 was calculated using Enzyme Linked Immunosprbent Assay (ELISA) and reported in ng/ml. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.
Time frame: Day 0 (Baseline), Day 4, Day 8
Satisfaction With Debridement: Overall Satisfaction With Method, Day 8
Satisfaction (Overall) item score. This item is from a Satisfaction with Debridement survey, designed to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Individual item scores range from 0 to 10, with higher scores indicating better outcomes (higher overall satisfaction).
Time frame: Day 8
Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8
Survey item score for Aesthetic Unpleasantness of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the aesthetic unpleasantness item indicating worse outcomes
Time frame: Day 8
Satisfaction: Difficulty of Use/Care, Day 8
Survey item score for Difficulty of Use/Care of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the difficulty item indicating worse outcome (higher difficulty of use/care for debridement method).
Time frame: Day 8
Satisfaction: Wound Pain, Day 8
Satisfaction survey to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Pain was measured using the Defense and Veterans Pain Rating Scale (DVPRS). Individual item scores range from 0 to 10, with higher scores on the DVPRS indicating higher pain and worse outcomes.
Time frame: Day 8
| Milestone | Larval Debridement Therapy (LDT) - Patients | Sharp Debridement Therapy (SDT) - Patients |
|---|---|---|
| Started | 23 | 22 |
| Completed | 18 | 16 |
| Not completed | 5 | 6 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Pt taking excluded medication | 3 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Wound healed | 0 | 2 |
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Tryptic Soy Agar (TSA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
| Natural Log Transformed Bacterial CFU | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Day 0 | 9.6561 ± 3.10402 | 9.6880 ± 1.75013 |
| Day 4 | 11.9611 ± 1.68800 | 9.1547 ± 2.57417 |
| Day 8 | 11.4864 ± 2.05378 | 10.4479 ± 2.25869 |
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with MacConkey Agar plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
| Natural Log Transformed Bacterial CFU | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Day 0 | 4.5512 ± 4.32429 | 5.4009 ± 4.76243 |
| Day 4 | 8.9408 ± 3.64582 | 6.2482 ± 4.32648 |
| Day 8 | 8.9198 ± 4.33985 | 6.8660 ± 4.80509 |
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Phenylethyl Alcohol (PEA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
| Natural Log Transformed Bacterial CFU | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Day 0 | 7.0633 ± 4.45210 | 8.7514 ± 1.56580 |
| Day 4 | 9.8704 ± 2.69279 | 8.5673 ± 2.64319 |
| Day 8 | 9.2877 ± 2.71007 | 9.7341 ± 2.52994 |
For each patient, wound photos were taken at days 0, 4, and 8 and given to wound specialists. Wound specialists reviewed photos to assess whether there was visible reduction in amount of necrotic or non-viable tissue remaining in the wound bed at day 8--i.e., whether the wound appeared to be improved (yes vs. no). The percentage of reviewers (out of 4) who responded "yes" that the wound appeared improved was calculated for each patient. Thus, each patient received a score for percentage of reviewers who saw visual improvement; the means and standard deviations for these percentages were compared between LDT and SDT groups. Higher scores correspond to better outcomes (higher proportion of reviewers who responded that wounds appeared visibly improved).
| percentage of reviewers | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Reviewer Assessment of Visible Wound Improvement | 61.11 ± 39.503 | 71.88 ± 32.755 |
Using Enzyme Linked Immunosprbent Assay (ELISA), the levels of active Matrix Metalloproteinase type 9 (MMP-9) was calculated and expressed as pg/ml of wound fluid and pg/mg protein. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.
| Natural Log Transformed MMP-9 in pg/ml | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Day 0 | 2.8538 ± 0.83493 | 2.8965 ± 0.87010 |
| Day 4 | 2.7847 ± 0.76985 | 2.7260 ± 0.71122 |
| Day 8 | 2.9985 ± 0.63257 | 2.6861 ± 0.84722 |
The levels of active IL6 was calculated using Enzyme Linked Immunosprbent Assay (ELISA) and reported in ng/ml. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.
| Natural Log Transformed IL6 in ng/ml | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Day 0 | 3.4889 ± 1.29396 | 3.5748 ± 1.94347 |
| Day 4 | 4.2287 ± 1.65271 | 4.2233 ± 1.18058 |
| Day 8 | 4.0069 ± 1.37460 | 4.0096 ± 1.68661 |
Satisfaction (Overall) item score. This item is from a Satisfaction with Debridement survey, designed to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Individual item scores range from 0 to 10, with higher scores indicating better outcomes (higher overall satisfaction).
| score on a scale | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Satisfaction With Debridement: Overall Satisfaction With Method, Day 8 | 7.27 ± 3.642 | 7.13 ± 3.642 |
Survey item score for Aesthetic Unpleasantness of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the aesthetic unpleasantness item indicating worse outcomes
| score on a scale | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8 | 2.63 ± 2.872 | 3.75 ± 4.266 |
Survey item score for Difficulty of Use/Care of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the difficulty item indicating worse outcome (higher difficulty of use/care for debridement method).
| score on a scale | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Satisfaction: Difficulty of Use/Care, Day 8 | 1.60 ± 2.530 | 1.88 ± 3.243 |
Satisfaction survey to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Pain was measured using the Defense and Veterans Pain Rating Scale (DVPRS). Individual item scores range from 0 to 10, with higher scores on the DVPRS indicating higher pain and worse outcomes.
| DVPRS (Pain) Score | Larval Debridement Therapy | Sharp Debridement Therapy |
|---|---|---|
| Satisfaction: Wound Pain, Day 8 | 4.14 ± 3.110 | 3.63 ± 3.284 |
Collected over period of time over which adverse event data were collected was 3 years (11/25/2014 to 11/25/2017).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Larval Debridement Therapy | 1/18 (5.6%) | 0/18 (0%) | 0/18 (0%) |
| Sharp Debridement Therapy | 1/16 (6.3%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| Mean | 65.9 ± 8.5 | 64.9 ± 6.6 | 65.4 ± 7.89 |
| Sex: Female, Male(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 16 | 13 | 29 |
| Race/Ethnicity, Customized(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| Black/African American | 3 | 4 | 7 |
| Hispanic/Latino | 0 | 1 | 1 |
| White/Caucasian | 11 | 11 | 22 |
| Other | 1 | 0 | 1 |
| Not documented | 3 | 0 | 3 |
| Region of Enrollment(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| United States | 18 | 16 | 34 |
| Current Smokers(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| Count of participants | 3 | 5 | 8 |
| History of wounds(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| History of diabetic lower extremity wounds | 10 | 11 | 21 |
| Venous leg ulcers | 4 | 3 | 7 |
| Other lower extremity wounds | 2 | 2 | 4 |
| None documented | 2 | 0 | 2 |
| Marital/partner status(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| Married/partner | 7 | 7 | 14 |
| Single | 8 | 9 | 17 |
| Widow/Widower | 1 | 0 | 1 |
| Declined to answer | 2 | 0 | 2 |
| Suspected duration of wound at enrollment(Participants) | Larval Debridement Therapy | Sharp Debridement Therapy | Total |
|---|---|---|---|
| Over 8 weeks unknown total duration | 2 | 1 | 3 |
| Over 8 weeks but under 6 months duration | 2 | 5 | 7 |
| Over 6 months but under 1 year duration | 7 | 2 | 9 |
| One year or longer duration | 5 | 8 | 13 |
| Not documented | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jan 2015, a primary completion of Dec 2017 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2020, 2 years 4 months after primary completion.
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North Florida Foundation for Research and Education