NCT02577900

Brief Summary

The purpose of this study is to determine whether nanocrystalline silver dressing, manuka honey dressing and conventional dressing are effective in the treatment of diabetic foot ulcer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Status
completed

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

February 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

October 11, 2015

Results QC Date

December 29, 2018

Last Update Submit

April 5, 2019

Conditions

Diabetic Foot

Keywords

foot ulcer and honey and silver

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Complete Healing of Ulcer During the Observation Period

    The number of participants have absence of a visible wound achieved by complete epithelialization

    12 weeks

Secondary Outcomes (4)

  • Change in Ulcer Size

    12 weeks

  • the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4

    Week 1, Week 4

  • the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4

    Week 1, Week 4

  • the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4

    Week 1, Week 4

Study Arms (3)

Acticoat absorbent

EXPERIMENTAL

Apply Acticoat absorbent onto the ulcer

Device: Acticoat absorbent

Honey gel sheet

ACTIVE COMPARATOR

Apply Honey gel sheet onto the ulcer

Device: Honey gel sheet

Jelonet

OTHER

Apply Jelonet onto the ulcer

Device: Jelonet

Interventions

Acticoat absorbentDEVICE

Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval

Also known as: nanocrystalline silver alginate
Acticoat absorbent
Honey gel sheetDEVICE

Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval

Also known as: Manuka honey alginate
Honey gel sheet
JelonetDEVICE

Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval

Also known as: paraffin tulle
Jelonet

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of type 2 diabetes mellitus and
  • Age 40 or above with foot ulcer and
  • Ulcer with size equals or larger than 1 cm in diameter and
  • Ulcer located at or below malleolar region of foot and
  • Superficial ulcer, ulcer penetrates to tendon or capsule and
  • Ulcer without infection, mild and moderate infection and
  • Subject with no foreseeable surgery within 12-week study period

You may not qualify if:

  • HbA1c level ≥ 10% or
  • Severe ischemia with ankle-brachial index (ABI) ≤ 0.4 or
  • Ulcer deep into bone and joint or
  • Osteomyelitis or
  • Severe ulcer infection or
  • Known allergy to manuka honey/ nanocrystalline silver or
  • Known case of venous ulcer or varicose vein or
  • Known case of benign or malignant tumor or
  • Known to have any auto-immune disease or
  • A condition requiring medication that affects the immune response or
  • Participation in other experimental treatment studies or
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic FootFoot Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesFoot Diseases

Results Point of Contact

Title
Dr. Tsang Ka-Kit
Organization
Queen Elizabeth Hospital
kktsang3@netvigator.com
+852-35062610

Study Officials

  • Tsang Ka Kit, Master

    Queen Elizabeth Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse consultant

Study Record Dates

First Submitted

October 11, 2015

First Posted

October 16, 2015

Study Start

February 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 16, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-04