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Diabetic Foot Ulcer Study on Topical Interventions (DFU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577900
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : January 23, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Tsang Ka Kit, Queen Elizabeth Hospital, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Device: Acticoat absorbent Device: Honey gel sheet Device: Jelonet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey and Conventional Dressing in Healing Diabetic Foot Ulcer
Study Start Date : February 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acticoat absorbent
Apply Acticoat absorbent onto the ulcer
Device: Acticoat absorbent
Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval
Other Name: nanocrystalline silver alginate

Active Comparator: Honey gel sheet
Apply Honey gel sheet onto the ulcer
Device: Honey gel sheet
Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval
Other Name: Manuka honey alginate

Jelonet
Apply Jelonet onto the ulcer
Device: Jelonet
Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
Other Name: paraffin tulle




Primary Outcome Measures :
  1. Number of Participants With Complete Healing of Ulcer During the Observation Period [ Time Frame: 12 weeks ]
    The number of participants have absence of a visible wound achieved by complete epithelialization


Secondary Outcome Measures :
  1. Change in Ulcer Size [ Time Frame: 12 weeks ]
  2. the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4 [ Time Frame: Week 1, Week 4 ]
  3. the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4 [ Time Frame: Week 1, Week 4 ]
  4. the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4 [ Time Frame: Week 1, Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577900


Sponsors and Collaborators
Queen Elizabeth Hospital, Hong Kong
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Tsang Ka Kit, Master Queen Elizabeth Hospital, Hong Kong
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Responsible Party: Tsang Ka Kit, Nurse consultant, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02577900    
Other Study ID Numbers: QEH-O&T-001
First Posted: October 16, 2015    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Tsang Ka Kit, Queen Elizabeth Hospital, Hong Kong:
foot ulcer and honey and silver
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases