Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
1 other identifier
interventional
80
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2005
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMarch 24, 2008
March 1, 2008
2.5 years
March 18, 2008
March 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to healing
weekly
Secondary Outcomes (2)
time to return to regular shoe gear
weekly
days unable to work
weekly
Study Arms (2)
experimental
EXPERIMENTALSubjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
Control
ACTIVE COMPARATORTopical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
Interventions
Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
Eligibility Criteria
You may qualify if:
- Ingrown toenails will be defined as any incurvated nail border that digs into the skin of the nail fold and causes pain and discomfort
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Scholl Foot and Ankle Center
North Chicago, Illinois, 60064, United States
Preofessional Education and Research Institutue
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David G Armstrong, DPM, PhD
Rosalind Franklin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
November 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 24, 2008
Record last verified: 2008-03