NCT03736109

Brief Summary

Osteoarthritis (OA) is one of the most common forms of degenerative joint disease and a major cause of pain and disability affecting the aging population. It is a significant burden in terms of cost as well as the health of society and individuals. Here in our study we will try to evaluate a novel therapeutic method by using topical copper-albumin complexes cream in treatment of osteoarthritis. Then all the biochemical changes will be measured beside the evaluation of topical copper-albumin complexes cream effectiveness in relieving symptoms of the OA.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

November 7, 2018

Last Update Submit

January 8, 2019

Conditions

Osteo Arthritis Knee

Keywords

Copper-Albumin ComplexOsteoarthritisSyndecan 4Substance Phyaluronic acidInsulin like growth factorNitric oxide

Outcome Measures

Primary Outcomes (1)

  • The mean difference of syndecan 4 expression and substance P before and after treatment

    better understanding the efficacy of the Copper-Albumin Complex treatment for knee osteoarthritis

    2 months

Secondary Outcomes (1)

  • Pain improvement

    2 months

Study Arms (2)

Group I:

Thirty patients with knee osteoarthritis taking topical Copper-Albumin Complex cream

Genetic: Soluble and genetic biomarkers measurements

Group II:

Thirty patients with knee osteoarthritis taking oral chondroprotective drugs

Genetic: Soluble and genetic biomarkers measurements

Interventions

Soluble and genetic biomarkers measurementsGENETIC

Insulin-Like Growth Factor-1 and Coll2-1 gene expression will be measured by real time PCR. In addition, syndecan 4, hyaluronic acid, substance P and nitric oxide will be measured in plasma by ELISA

Group I:Group II:

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Knee osteoarthritis patients

You may qualify if:

  • Patients of both sexes and over 40 years of age diagnosed with unilateral or bilateral symptomatic OA of the knee who met the criteria of the American College of Rheumatology (ACR).
  • Patients who were rated grade II or III on the Kellgren and Lawrence (K\&L) radiological scale \[19\].
  • Patients with symptomatic OA with a global mean pain in the knee \>40 mm on a Visual Analogue Scale (VAS) for pain assessment.

You may not qualify if:

  • Women who were pregnant or breastfeeding
  • Patients who were grade I or IV on K\&L radiological scale.
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Bai Z, Guo XH, Tang C, Yue ST, Shi L, Qiang B. Effects of Artesunate on the Expressions of Insulin-Like Growth Factor-1, Osteopontin and C-Telopeptides of Type II Collagen in a Rat Model of Osteoarthritis. Pharmacology. 2018;101(1-2):1-8. doi: 10.1159/000479160. Epub 2017 Sep 13.

    PMID: 28898893BACKGROUND

  • Duncan C, White AR. Copper complexes as therapeutic agents. Metallomics. 2012 Feb;4(2):127-38. doi: 10.1039/c2mt00174h. Epub 2011 Dec 20.

    PMID: 22187112BACKGROUND

  • Moller I, Gharbi M, Martinez Serrano H, Herrero Barbero M, Verges Milano J, Henrotin Y. Effect of chondroitin sulfate on soluble biomarkers of osteoarthritis: a method to analyze and interpret the results from an open-label trial in unilateral knee osteoarthritis patients. BMC Musculoskelet Disord. 2016 Oct 6;17(1):416. doi: 10.1186/s12891-016-1268-4.

    PMID: 27716158BACKGROUND

  • Bay-Jensen AC, Thudium CS, Mobasheri A. Development and use of biochemical markers in osteoarthritis: current update. Curr Opin Rheumatol. 2018 Jan;30(1):121-128. doi: 10.1097/BOR.0000000000000467.

    PMID: 29040157BACKGROUND

  • Ding H, Wu T. Insulin-Like Growth Factor Binding Proteins in Autoimmune Diseases. Front Endocrinol (Lausanne). 2018 Aug 30;9:499. doi: 10.3389/fendo.2018.00499. eCollection 2018.

    PMID: 30214426BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

reham elmahdy, Lecturer

CONTACT

+201002714637rehamibrahimelmahdy@gmail.com

Ahmed yassein nassar, Professor

CONTACT

+201149511340aynassar41@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

January 17, 2019

Primary Completion

March 20, 2019

Study Completion

March 30, 2019

Last Updated

January 10, 2019

Record last verified: 2019-01