Wound HealingTOPCGP-2008NCT01264588
The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring
A study testing Topical calcium glycerophosphate lotion in people with Wound Healing and Scarring, run by AkPharma Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Wound Healing, Scarring
- What is being tested?
- Topical calcium glycerophosphate lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent must be obtained
- 45-75 years of age
- Scheduled for bilateral knee replacement surgery
Who cannot join
- Employee or immediate family of either AkPharma or employee or immediate family of investigator or site personnel
- Pregnant or breast feeding Known allergy or hypersensitivity to calcium or phosphorus supplements
- Diagnosed with type I or type II diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Institute Orthopaedics
Egg Harbor, New Jersey, 08234
About this study
Official title: A Randomized, Single Blind, Comparative, Controlled Study On The Effects Of Topical Calcium Glycerophosphate On Surgical Wound Healing And Residual Scarring In Bilateral Total Knee Arthroplasty Patients
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
- Conditions
- Wound Healing, Scarring
- Being tested
- Topical calcium glycerophosphate lotion
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical calcium glycerophosphate lotionOther
2g once daily for 6 weeks (post-op day 3 thru 42)
| Study group | Role | What they receive |
|---|---|---|
| topical calcium glycerophosphate lotion | Active comparator | Not described Receives: Other: Topical calcium glycerophosphate lotion |
| standard-of-care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of surgical wound appearance
Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in the time required for wound closure and/ or scar minimization between treated and untreated groups.
Measured: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Secondary outcomes (4)
Reduction of visible erythema/ inflammation
Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in reduction of visible erythema/ inflammation between treated and untreated groups.
Measured: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Scar minimization or prevention
Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in scar appearance between treated and untreated groups.
Measured: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Incision/ scar pain and sensitivity
Subjects are asked to rate their pain at the site of incision for each knee, using a scale of 0 (no pain) to 10 (excruciating pain). The pain evaluations are recorded on a pain diary sheet provided at each time point.
Measured: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Range of motion
Range of motion (both flexion and extension) is evaluated using standard goniometric methods.
Measured: Post-Op Day: 3 (baseline), 7, 42, 180, 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AkPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rothman Institute Orthopaedics, Texas Tech University Health Sciences Center, Cyberderm Inc., Bacharach Institute for Rehabilitation, Pomona, NJ
- Investigators
- Alvin C. Ong, M.D., Principal investigator, Rothman Institute Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264588
- Sponsor's protocol ID
- TOPCGP-2008
- Acronym
- TOPCGP-2008
- Status last verified
- Dec 2010
- First submitted
- 20 Dec 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Comparative, Controlled Study On The Effects Of Topical Calcium Glycerophosphate On Surgical Wound Healing And Residual Scarring In Bilateral Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT01264588
- Acronym / sponsor ID
- TOPCGP-2008 / TOPCGP-2008
- Conditions
- Wound Healing, Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AkPharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rothman Institute Orthopaedics, Texas Tech University Health Sciences Center, Cyberderm Inc., Bacharach Institute for Rehabilitation, Pomona, NJ
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical calcium glycerophosphate lotion | Active comparator | Other: Topical calcium glycerophosphate lotion |
| standard-of-care | No intervention | – |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent must be obtained
- 45-75 years of age
- Scheduled for bilateral knee replacement surgery
Key exclusion criteria (3 listed)
- Employee or immediate family of either AkPharma or employee or immediate family of investigator or site personnel
- Pregnant or breast feeding Known allergy or hypersensitivity to calcium or phosphorus supplements
- Diagnosed with type I or type II diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical calcium glycerophosphate lotion2g once daily for 6 weeks (post-op day 3 thru 42) | Other | topical calcium glycerophosphate lotion |
Primary outcome
Improvement of surgical wound appearance
Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in the time required for wound closure and/ or scar minimization between treated and untreated groups.
4 secondary outcomes
Reduction of visible erythema/ inflammation
Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Scar minimization or prevention
Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Incision/ scar pain and sensitivity
Time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Range of motion
Time frame: Post-Op Day: 3 (baseline), 7, 42, 180, 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvin C. Ong, M.D. principal investigator
Rothman Institute Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical calcium glycerophosphate lotion in people with Wound Healing and Scarring, run by AkPharma Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of surgical wound appearance (time frame: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2010.