Stage IV Pressure UlcerEAPSTIMVGNCT06808568
Expanded Access Program (EAP) STIMULAN VG
A study testing STIMULAN VG in people with Stage IV Pressure Ulcer and Diabetic Foot Osteomyelitis, run by Biocomposites Ltd.
Trial summary
Individual (single) patient expanded access may be considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Pressure Ulcer, Diabetic Foot Osteomyelitis
- What is being tested?
- STIMULAN VG
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Individual (single) patient expanded access may be considered.
Read the detailed description
Patients facing serious or life-threatening illnesses who have exhausted currently available treatment options and are ineligible or unable to participate in a clinical trial may decide to explore therapeutic use of investigational drugs with their healthcare providers.
Under these circumstances, single-patient access can be requested from a licensed treating physician on behalf of the patient.
Please contact expandedaccess@biocomposites.com for more information.
- Being tested
- STIMULAN VG
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIMULAN VGCombination product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Pressure UlcerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Biocomposites Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808568
- Sponsor's protocol ID
- EAPSTIMVG
- Acronym
- EAPSTIMVG
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program (EAP) STIMULAN VG
- ClinicalTrials.gov ID
- NCT06808568
- Acronym / sponsor ID
- EAPSTIMVG / EAPSTIMVG
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Biocomposites LtdIndustry (pharma, biotech, devices)
- First posted
- 5 Feb 2025 (actual)
- 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.
Individual (single) patient expanded access may be considered.
Detailed description
Patients facing serious or life-threatening illnesses who have exhausted currently available treatment options and are ineligible or unable to participate in a clinical trial may decide to explore therapeutic use of investigational drugs with their healthcare providers.
Under these circumstances, single-patient access can be requested from a licensed treating physician on behalf of the patient.
Please contact expandedaccess@biocomposites.com for more information.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| STIMULAN VG | Combination product | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Related trials for Stage IV Pressure Ulcer
RecruitingPhase 2
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
Pressure Ulcer, Stage IV, Osteomyelitis
Recruiting
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Pressure Ulcers Stage II, Pressure Ulcers Stage III
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.
Questions about this trial
What is this clinical trial studying?
A study testing STIMULAN VG in people with Stage IV Pressure Ulcer and Diabetic Foot Osteomyelitis, run by Biocomposites Ltd.
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 1 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Biocomposites Expanded Access Team (+44 (0) 1782 338 580, expandedaccess@biocomposites.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 5 Feb 2025.