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A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

Primary Purpose

Wound Heal, Necrotic Tissue Removal

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Honey Impregnated Dressing

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female at least 18 years of age
Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration
Must have necrotic tissue at least 25% of wound area
The wound type matches one of the indicated wounds listed on the product labeling:
Leg ulcers
Pressure ulcers
Diabetic foot ulcers
First and second degree burns
Surgical wounds
Trauma wounds
Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants
Type I/II diabetic subjects that meet the following criteria:
Random blood glucose is less than 450 mg/dL within 30 days of the screening visit

Exclusion Criteria:

Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product
The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation
Wound duration ≥ 52 weeks
The subject has a prognosis that indicated unlikely survival past the study period
The subject is currently receiving dialysis
Gangrene is present in the target wound
Patient's wound is infected
The subject's diagnosis indicates third degree burns
The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study
In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements

Sites / Locations

Northern Illinois Foot & Ankle Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Honey Impregnated Dressing

Arm Description

Honey Impregnated Dressing

Outcomes

Primary Outcome Measures

Change in Necrotic Tissue

The percent change in necrotic tissue will serve as the primary endpoint.

Secondary Outcome Measures

Wound Closure

Percent of patients with 100% wound closure in each group

Infections

Number of infections in the wound sites will be recorded.

Odor

The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor.

Pain Score

The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain.

Bates-Jensen Wound Assessment Tool Score

The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65.

Full Information

NCT ID

NCT03412929

First Posted

January 11, 2018

Last Updated

March 30, 2020

Sponsor

Medline Industries

1. Study Identification

Unique Protocol Identification Number

NCT03412929

Brief Title

A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

Official Title

A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

January 10, 2019 (Actual)

Study Completion Date

May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medline Industries

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Heal, Necrotic Tissue Removal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Honey Impregnated Dressing

Arm Type

Experimental

Arm Description

Honey Impregnated Dressing

Intervention Type

Device

Intervention Name(s)

Honey Impregnated Dressing

Intervention Description

The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.

Primary Outcome Measure Information:

Title

Change in Necrotic Tissue

Description

The percent change in necrotic tissue will serve as the primary endpoint.

Time Frame

From initial date of application to weekly visits assessed up to 4 weeks.

Secondary Outcome Measure Information:

Title

Wound Closure

Description

Percent of patients with 100% wound closure in each group

Time Frame

From initial date of application to weekly visits assessed up to 4 weeks.

Title

Infections

Description

Number of infections in the wound sites will be recorded.

Time Frame

From initial date of application to weekly visits assessed up to 4 weeks.

Title

Odor

Description

The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor.

Time Frame

The odor score will be recorded at weekly visits over four weeks for each subject.

Title

Pain Score

Description

The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain.

Time Frame

The pain score will be recorded at weekly visits over four weeks for each subject.

Title

Bates-Jensen Wound Assessment Tool Score

Description

Time Frame

The BWAT score will be recorded at weekly visits over fours weeks for each subject.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female at least 18 years of age Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration Must have necrotic tissue at least 25% of wound area The wound type matches one of the indicated wounds listed on the product labeling: Leg ulcers Pressure ulcers Diabetic foot ulcers First and second degree burns Surgical wounds Trauma wounds Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures. Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants Type I/II diabetic subjects that meet the following criteria: Random blood glucose is less than 450 mg/dL within 30 days of the screening visit Exclusion Criteria: Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation Wound duration ≥ 52 weeks The subject has a prognosis that indicated unlikely survival past the study period The subject is currently receiving dialysis Gangrene is present in the target wound Patient's wound is infected The subject's diagnosis indicates third degree burns The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements

Facility Information:

Facility Name

Northern Illinois Foot & Ankle Specialists

City

Lake In The Hills

State/Province

Illinois

ZIP/Postal Code

60156

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

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