NCT02448511

Brief Summary

This study evaluates the efficacy of local application of ozone gas in healing of infected ulcers. Half the participants received conventional treatment with placebo generator and the other half received conventional treatment with ozone generator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

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

August 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

9 months

First QC Date

May 12, 2015

Last Update Submit

May 14, 2015

Conditions

UlcerWound Infection

Keywords

ozone gasulcerinfected ulcer

Outcome Measures

Primary Outcomes (1)

  • wound healing

    wound closure rate

    75 days

Study Arms (2)

Ozone

EXPERIMENTAL

this group received local application of ozone gas in addition to conventional treatment.

Other: OzoneOther: Conventional treatment

Placebo

SHAM COMPARATOR

This group received sham treatment in addition to conventional treatment

Device: PlaceboOther: Conventional treatment

Interventions

OzoneOTHER

ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.

Also known as: Ozone gas
Ozone
PlaceboDEVICE

a similar looking device was applied to the affected part for a period of one hour each day under sub atmospheric condition. the device did not produce any gas.

Also known as: sham comparator
Placebo
Conventional treatmentOTHER

Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups

OzonePlacebo

Eligibility Criteria

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

You may qualify if:

  • infected ulcer size of atleast 10 cm.
  • patient willing to participate in the study and for follow up.

You may not qualify if:

  • patient unwilling for participation and follow up.
  • chronic kidney disease,
  • peripheral occlusive vascular disease,
  • venous ulcers,
  • pressure sores,
  • use of immuno suppressant drugs,
  • immunosuppressed state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John's Medical College Hospital

Bangalore, Karnataka, 560034, India

Location

Related Publications (4)

  • Bocci VA. Scientific and medical aspects of ozone therapy. State of the art. Arch Med Res. 2006 May;37(4):425-35. doi: 10.1016/j.arcmed.2005.08.006.

    PMID: 16624639BACKGROUND

  • Zhang J, Guan M, Xie C, Luo X, Zhang Q, Xue Y. Increased growth factors play a role in wound healing promoted by noninvasive oxygen-ozone therapy in diabetic patients with foot ulcers. Oxid Med Cell Longev. 2014;2014:273475. doi: 10.1155/2014/273475. Epub 2014 Jun 24.

    PMID: 25089169RESULT

  • Wainstein J, Feldbrin Z, Boaz M, Harman-Boehm I. Efficacy of ozone-oxygen therapy for the treatment of diabetic foot ulcers. Diabetes Technol Ther. 2011 Dec;13(12):1255-60. doi: 10.1089/dia.2011.0018. Epub 2011 Jul 13.

    PMID: 21751891RESULT

  • Martinez-Sanchez G, Al-Dalain SM, Menendez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernandez-Montequin JI, Leon OS. Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Oct 31;523(1-3):151-61. doi: 10.1016/j.ejphar.2005.08.020. Epub 2005 Sep 29.

    PMID: 16198334RESULT

Related Links

MeSH Terms

Conditions

UlcerWound Infection

Interventions

Ozone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfections

Intervention Hierarchy (Ancestors)

OxygenGasesInorganic Chemicals

Study Officials

  • Anthony P Rozario, DNS,FRCS

    St Johns Medical College Hospital, Bangalore, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 19, 2015

Study Start

August 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

IN(1)