Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| North Florida/South Georgia Veterans Health System | OTHER |
| Biomonde | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Larval Debridement Therapy | Active Comparator | 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. |
|
| Sharp Debridement Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Larval Debridement Therapy | Device | small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Day 0 (Baseline), Day 4, Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Linda J Cowan, PhD | North Florida/South Georgia Veterans Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | United States | ||
| North Florida / South Georgia Veterans Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34398099 | Derived | Sen CK, Roy S, Mathew-Steiner SS, Gordillo GM. Biofilm Management in Wound Care. Plast Reconstr Surg. 2021 Aug 1;148(2):275e-288e. doi: 10.1097/PRS.0000000000008142. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Larval Debridement Therapy (LDT) - Patients | 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. Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm |
| FG001 | Sharp Debridement Therapy (SDT) - Patients | 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. Bedside Sharp Debridement: 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Larval Debridement Therapy | 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. Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more days of measurement. | Posted | Mean | Standard Deviation | Natural Log Transformed Bacterial CFU | Day 0 (Baseline), Day 4, Day 8 |
|
period of time over which adverse event data were collected was 3 years (11/25/2014 to 11/25/2017).
definitions were not different, any adverse event reported by participant, clinician, or study team were recorded and reported to IRB as per regulatory protocol
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Larval Debridement Therapy | 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. Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm |
Not provided
Not provided
This study was underpowered to observe significant difference between SDT and LDT groups. Aversion to LDT we anticipated in subjects, caregivers, and clinicians were not encountered. Almost all subjects in SDT group elected to try LDT after study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Cowan | James A. Haley Veterans Hospital and Clinics | 813-558-3932 | linda.cowan@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2018 | Nov 26, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D001424 | Bacterial Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096383 | Maggot Debridement Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bedside Sharp Debridement | Procedure | 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 |
|
|
| 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. | 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. | 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). | 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 | 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). | 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. | Day 8 |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Protocol Violation |
|
| Lost to Follow-up |
|
| wound healed |
|
| BG001 | Sharp 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. Bedside Sharp Debridement: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Current Smokers | Count of Participants | Participants |
|
| History of wounds | Count of Participants | Participants |
|
| Marital/partner status | Count of Participants | Participants |
|
| Suspected duration of wound at enrollment | Count of Participants | Participants |
|
| OG001 | Sharp 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. Bedside Sharp Debridement: 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 |
|
|
|
| Primary | 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). | Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement. | Posted | Mean | Standard Deviation | Natural Log Transformed Bacterial CFU | Day 0 (Baseline), Day 4, Day 8 |
|
|
|
|
| Primary | 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). | Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement. | Posted | Mean | Standard Deviation | Natural Log Transformed Bacterial CFU | Day 0 (Baseline), Day 4, Day 8 |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | percentage of reviewers | Day 8 |
|
|
|
|
| Secondary | 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. | Statistical analysis was performed on a subset of participants (n=20) due to missing data on one or more days of measurement. | Posted | Mean | Standard Deviation | Natural Log Transformed MMP-9 in pg/ml | Day 0 (Baseline), Day 4, Day 8 |
|
|
|
|
| Secondary | 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. | Statistical analysis was performed on a subset of participants (n=27) due to missing data on one or more days of measurement. | Posted | Mean | Standard Deviation | Natural Log Transformed IL6 in ng/ml | Day 0 (Baseline), Day 4, Day 8 |
|
|
|
|
| Secondary | 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). | Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
|
|
|
| Secondary | 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 | Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more measures. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
|
|
|
| Secondary | 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). | Statistical analysis was performed on a subset of participants (n=31) due to missing data on one or more measures. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
|
|
|
| Secondary | 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. | Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures. | Posted | Mean | Standard Deviation | DVPRS (Pain) Score | Day 8 |
|
|
|
|
| 1 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Sharp 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. Bedside Sharp Debridement: 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 | 1 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D001423 | Bacterial Infections and Mycoses |
| Day 8 |
|
| Day 8 |
|
| Day 8 |
|
| Day 8 |
|