NCT02482948

Brief Summary

The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

June 12, 2015

Last Update Submit

November 30, 2017

Conditions

UlcerWounds

Keywords

Debridementcollagenaseleptospermum honey

Outcome Measures

Primary Outcomes (1)

  • Necrotic tissue reduction

    Necrotic tissue percent reduction in the wound at the end of 14 days

    two weeks

Secondary Outcomes (1)

  • Percent wound reduction

    4 weeks

Study Arms (2)

Collagenase

ACTIVE COMPARATOR

This is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily

Drug: Collagenase

Active leptospermum honey

ACTIVE COMPARATOR

This is an active medicinal grade honey used to promote autolytic debridement and applied daily

Device: Active Leptospermum Honey (Medihoney)

Interventions

Active Leptospermum Honey (Medihoney)DEVICE

STudy agent to be applied to the wound daily.

Also known as: Medihoney
Active leptospermum honey
CollagenaseDRUG

Study agent to be applied daily to the wound.

Also known as: Santyl
Collagenase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A signed and dated informed consent has been obtained from the subject.
  • Subject is able and willing to comply with study procedures.
  • Subject is able to comply with weekly visits.
  • Subject is 18 years of age or older.
  • There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of \> 1cm2 to \< 64cm2.
  • Subject will not have currently used parenteral or oral antibiotics except for UTI.
  • Diabetic subjects: HbA1c \< 12.0 % within 90 days preceding enrollment.
  • Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment.
  • Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed.
  • Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory.
  • Subject with a venous ulcer must be currently receiving and using compression therapy that can be managed daily.
  • Subject and caregiver are trainable and able to perform dressing changes.
  • Subject has no allergies to collagenase or honey.
  • Subject has no allergies to semi-occlusive or absorptive secondary dressing.

You may not qualify if:

  • Steroid use \>5mg daily.
  • Subject is unable to cooperate with offloading and/or compression recommendations.
  • ABI = or \>0.8 if the wound is located on a lower extremity.
  • Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment.
  • Subject has medical instability as deemed by the investigator.
  • Subject is pregnant.
  • Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovative Healing Systems

Tampa, Florida, 33614, United States

Location

MeSH Terms

Conditions

UlcerWounds and Injuries

Interventions

Collagenases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Officials

  • Ravi Patel, MD

    Innovative Healing Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 26, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

US(1)