Ingrown NailNCT00641433
Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
A study testing oxidized regenerated cellulose collagen-silver and topical silver sulfadiazine cream in people with Ingrown Nail, run by Rosalind Franklin University of Medicine and Science at 2 sites in United States.
Trial summary
This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ingrown Nail
- What is being tested?
- oxidized regenerated cellulose collagen-silver and topical silver sulfadiazine cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to May 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ingrown toenails will be defined as any incurvated nail border that digs into the skin of the nail fold and causes pain and discomfort
Who cannot join
- Patients with immunocompromised states
- chronic steroid use
- diabetes mellitus
- collagen vascular disease
- HIV infection
- Cellulitis proximal to the hallux interphalangeal joint or peripheral vascular disease will be excluded
- We will define peripheral vascular disease as the absence of one or more pedal pulses or the presence of dystrophic changes to the integument
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Scholl Foot and Ankle Center
North Chicago, Illinois, 60064
Ryan T Crews, MS, 847-578-8437, ryan.crews@rosalindfranklin.edu
David Armstrong, DPM, PhD
- Recruiting
Preofessional Education and Research Institutue
Roanoke, Virginia, 24016
Charles Zelen, DPM, 540-725-5027, cmzelen@periedu.com
Charles Zelen, DPM
About this study
Official title: Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial
This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.
- Conditions
- Ingrown Nail
- Being tested
- oxidized regenerated cellulose collagen-silver, topical silver sulfadiazine cream
- Keywords
- chemocautery
- Medical subject headings
- Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxidized regenerated cellulose collagen-silverDevice
Also called Prisma
Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
topical silver sulfadiazine creamDrug
Also called Silvadene, Thermazene
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs. Receives: Device: oxidized regenerated cellulose collagen-silver |
| Control | Active comparator | Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured. Receives: Drug: topical silver sulfadiazine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to healing
Measured: weekly
Secondary outcomes (2)
time to return to regular shoe gear
Measured: weekly
days unable to work
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startNov 2005
- Primary completionMay 2008 (estimated)
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown NailStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Investigators
- David G Armstrong, DPM, PhD, Principal investigator, Rosalind Franklin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641433
- Sponsor's protocol ID
- ORT 014
- Status last verified
- Mar 2008
- First submitted
- 18 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00641433
- Acronym / sponsor ID
- ORT 014
- Conditions
- Ingrown Nail
- Keywords
- chemocautery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2008 (estimated)
- First posted
- 24 Mar 2008 (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.
This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Device: oxidized regenerated cellulose collagen-silverSubjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs. |
| Control | Active comparator | Drug: topical silver sulfadiazine creamTopical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ingrown toenails will be defined as any incurvated nail border that digs into the skin of the nail fold and causes pain and discomfort
Key exclusion criteria (7 listed)
- Patients with immunocompromised states
- Cellulitis proximal to the hallux interphalangeal joint or peripheral vascular disease will be excluded
- We will define peripheral vascular disease as the absence of one or more pedal pulses or the presence of dystrophic changes to the integument
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 |
|---|---|---|
| oxidized regenerated cellulose collagen-silverAlso: PrismaWound dressed daily with oxidized regenerated cellulose collagen-silver matrix. | Device | experimental |
| topical silver sulfadiazine creamAlso: Silvadene, ThermazeneCream will be applied to nailbed daily and dressed with a bandage until healing occurs. | Drug | Control |
Primary outcome
time to healing
Time frame: weekly
2 secondary outcomes
time to return to regular shoe gear
Time frame: weekly
days unable to work
Time frame: weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
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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.
David G Armstrong, DPM, PhD principal investigator
Rosalind Franklin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxidized regenerated cellulose collagen-silver and topical silver sulfadiazine cream in people with Ingrown Nail, run by Rosalind Franklin University of Medicine and Science at 2 sites 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David G Armstrong, DPM, PhD (847-578-8440, david.armstrong@rosalindfranklin.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to healing (time frame: weekly). 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 24 Mar 2008.