NCT02274207

Brief Summary

The purpose of this study is to test therapeutic benefits of silver dressing compared with non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may antibacterial effect on infected diabetes mellitus foot.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

September 2, 2014

Last Update Submit

November 22, 2015

Conditions

Diabetes Mellitus

Keywords

Silver dressingNPWTDMFfoot

Outcome Measures

Primary Outcomes (1)

  • Days to patient discharge

    -Examine the days from applied medical device to discharge.

    up to 4 weeks

Secondary Outcomes (9)

  • Days to infection clearance in wound culture results

    4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))

  • Complete infection clear rate in wound culture results

    up to 4 months

  • Days to complete wound closure

    4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))

  • Wound closure rate

    up to 4 months

  • Elevation of wound evaluations grade

    4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))

  • +4 more secondary outcomes

Study Arms (2)

silver dressing

EXPERIMENTAL

Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea

Device: NPWT application

non-silver dressing

ACTIVE COMPARATOR

Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea

Device: NPWT application

Interventions

NPWT applicationDEVICE

NPWT mode is cyclic mode : -125\~-50 mmHg

non-silver dressingsilver dressing

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient above 20 years and has type I, II of diabetes mellitus foot ulcer
  • Infected ulcer has one of below.
  • clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling
  • induration, purulent discharge etc.
  • Confirmed case of bacteria in wound culture.
  • Conformed case of abnormal range of erythrocyte sedimentation rate (ESR)/C-reactive protein(CRP) level in lab.
  • Has to be applied NPWT because suture is impossible in ulcer area.
  • The patient voluntary agreed to this protocol.
  • In the opinion of investigator, It is suitable to participate in this study.

You may not qualify if:

  • Infection in bone so patient need amputation
  • Female with childbearing, lactating or not agree to prevent pregnancy.
  • Has Sepsis, Osteomyelitis
  • Has Connective tissue disease of disturbance of healing of wound Ex) Rheumarthritis,systemic lupus erythematosus(SEL), myalgia.
  • The patient to diagnosis of Sickle sell disease or Charcot's joint.
  • The patient stability treated chronic wasting disease.
  • Malignant tumor or history of malignant disease. (Not diagnosis of complete recovery.)
  • The patient treated chemotherapy, radiation therapy, immune-suppressants therapy,adrenocortical hormones therapy.
  • Although necrosis tissue is removed, the target ulcer did not heal because of gangrenous, necrosis tissue or purulent pyorrhea.
  • Has ulcer with cardiac arrhythmia thrombus, venous insufficiency, diabetic necrobiosis lipoidic.
  • In case of using prohibited concomitant medications during study.
  • a. Oral system steroid b. Immune-suppressive drug c. Unfractionated heparin infusion d. improper drugs in the opinion of investigator.
  • Hypersensitivity with applicators. (NPWT, Silver)
  • The patient participated in other clinical trials within 30 days
  • In the opinion of investigator, the patient is not suitable to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • WooJin Choi, MD

    Korea: Severance hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woo Jin Choi, MD

CONTACT

82)2-2228-2195choiwj@yuhs.ac

Heiji Han, bachelor

CONTACT

82)10-5086-7812bohemi_han@naver.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedics

Study Record Dates

First Submitted

September 2, 2014

First Posted

October 24, 2014

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

KR(1)