Diabetic Foot UlcersPhase 1NCT00916292
Safety Study of Topical Human FGF-1 for Wound Healing
A Phase 1 study testing FGF-1 141 in people with Diabetic Foot Ulcers, run by Phage Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- FGF-1 141
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2013
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
- Age must be between 18 to 75 years of age.
- Female subject must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, and her serum pregnancy test is negative.
- Subjects must be willing to change their wound dressings daily and demonstrate to study personnel the ability to follow the dressing care instructions indicated in the Appendix. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.
Who cannot join
- Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
- Subjects who, at study entry, are taking systemic antibiotics.
- Subjects who are immunosuppressed.
- Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
- Past history or current presence of any type of cancer (except past history of basal cell carcinoma that is not on the limb being treated). Subjects with existing BCC will be excluded from the study.
- Life expectancy of less than 1 year.
Show all 12Show fewer
- Active alcohol or drug abuse within 6 months prior to study entry.
- Screening liver function tests of more than 2.0 times the upper limit of normal.
- Serum creatinine of ≥ 2.5 mg/dl.
- Hemoglobin A1c (HgbA1c) of >10%.
- Exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry.
- Any other medical, social, or geographical factor that would make it unlikely that the subject will comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of non-compliance).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dedicated Phase I
Phoenix, Arizona, 85013
Shawn Searle, MD, 602-279-7300
About this study
Official title: A Phase 1a, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Normal Volunteers Given Punch Skin Biopsies
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
Read the detailed description
Dermal ulcers pose a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. FGF-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- FGF-1 141
- Keywords
- Diabetes, dermal ulcers
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGF-1 141Drug
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. Low dose: FGF-1, 0.3 mg per square centimeter.
FGF-1 141Drug
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. High dose: FGF-1, 3.0 mg per square centimeter.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Four subjects will receive low dose FGF-1 Receives: Drug: FGF-1 141 |
| High Dose | Experimental | Four subjects will receive high dose FGF-1 Receives: Drug: FGF-1 141 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
Measured: 1 week
Secondary outcomes (1)
Serum levels of FGF-1 after topical administration
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startNov 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phage Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shawn Searle, MD, Principal investigator, Dedicated Phase I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916292
- Sponsor's protocol ID
- Phage-W2009-01-1a
- Status last verified
- Mar 2012
- First submitted
- 5 Jun 2009
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Normal Volunteers Given Punch Skin Biopsies
- ClinicalTrials.gov ID
- NCT00916292
- Acronym / sponsor ID
- Phage-W2009-01-1a
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetes, dermal ulcers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Phage Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 9 Jun 2009 (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 the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
Detailed description
Dermal ulcers pose a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. FGF-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: FGF-1 141Four subjects will receive low dose FGF-1 |
| High Dose | Experimental | Drug: FGF-1 141Four subjects will receive high dose FGF-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
- Age must be between 18 to 75 years of age.
- Female subject must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, and her serum pregnancy test is negative.
- Subjects must be willing to change their wound dressings daily and demonstrate to study personnel the ability to follow the dressing care instructions indicated in the Appendix. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.
Key exclusion criteria (12 listed)
- Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
- Subjects who, at study entry, are taking systemic antibiotics.
- Subjects who are immunosuppressed.
- Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
- Past history or current presence of any type of cancer (except past history of basal cell carcinoma that is not on the limb being treated). Subjects with existing BCC will be excluded from the study.
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 |
|---|---|---|
| FGF-1 141Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. Low dose: FGF-1, 0.3 mg per square centimeter. | Drug | Low dose |
| FGF-1 141Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control. High dose: FGF-1, 3.0 mg per square centimeter. | Drug | High Dose |
Primary outcome
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
Time frame: 1 week
1 secondary outcome
Serum levels of FGF-1 after topical administration
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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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.
Shawn Searle, MD principal investigator
Dedicated Phase I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FGF-1 141 in people with Diabetic Foot Ulcers, run by Phage Pharmaceuticals, 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 4 inclusion and 12 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 12 Mar 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound (time frame: 1 week). 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 12 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.