## Protocol Section
### Identification Module
**NCT ID:** NCT06283979

**Acronym:** BLADE OPU2

**Brief Title:** 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.

**Official Title:** A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

#### Organization Study ID Info
**ID:** 199723
#### Organization
**Class:** INDUSTRY
**Full Name:** Biocomposites Ltd
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-02-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-21
**Study First Submit QC Date:** 2024-02-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** MCRA

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Biocomposites Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

**Detailed Description:** The trial is an open-label, multi-center, randomized (1:1), controlled phase 2 trial in patients diagnosed with stage IV pressure ulcers.

### Conditions Module

**Conditions:**

- Pressure Ulcer, Stage IV

- Osteomyelitis

**Keywords:**

- between-group effect size

- surgical debridement

- ulcer bursectomy

- systemic antibiotics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity.

Flap closure. Peri-operative antibiotics.

**Intervention Names:**

- Combination Product: STIMULAN VG

- Procedure: Standard of Care

**Label:** Interventional STIMULAN VG

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Ulcer bursectomy, debridement and flap closure. Peri-operative antibiotics.

**Intervention Names:**

- Procedure: Standard of Care

**Label:** Standard of Care (SoC)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interventional STIMULAN VG

**Description:** Insertion of STIMULAN VG into the ulcer cavity prior to flap closure.

**Name:** STIMULAN VG

**Type:** COMBINATION_PRODUCT

#### Intervention 2

**Arm Group Labels:**

- Interventional STIMULAN VG

- Standard of Care (SoC)

**Description:** Standard of Care. Ulcer bursectomy, debridement and flap closure. Peri-operative antibiotics.

**Name:** Standard of Care

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.

**Measure:** Individual patient success and findings at the 8 week follow-up visit

**Time Frame:** 8 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

In order to be eligible to participate in this study, subjects must meet all of the following criteria:

1. Presenting with a Stage IV pressure ulcers requiring treatment of excision, bony debridement and flap coverage.
2. Operative candidate for flap surgery.
3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.
4. Adults ≥ 18 years in age at the time of treatment.
5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participating in this study:

1. Reasons contributing to pressure ulcer cannot be addressed.
2. Patients receiving primary closure
3. Severe immunological compromised patients as determined by the clinician.
4. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.
5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures.
6. Current smoker.
7. Diabetic patient with Hba1C level above 9.
8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).
9. Concurrent involvement in a study of another investigational product.
10. Pregnant or planning to become pregnant during study period.
11. Flexion contractures where patient cannot passively get full extension.
12. Uncontrolled muscle spasms.
13. Unable to comply with bedrest restriction.
14. Unable to provide consent.
15. Fecal or urinary incontinence with contamination of the wound.
16. Unable to achieve wheelchair and cushion offloading of pressure wound prior to surgery - as demonstrated by pressure mapping.
17. Investigator considers the participant to be clinically malnourished.
18. Any conditions with known hypercalcemia (\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).
19. Investigator believes trial participation may compromise safety of the participant or trial results.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@biocomposites.com

**Name:** Keira Watts, Clinical Project Manager

**Phone:** +44 (0) 1782 338 580

**Role:** CONTACT

**Contact 2:**

**Email:** nvillagomez@mcra.com

**Name:** Nicole Villagomez

**Phone:** (202) 552-5800

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000001850

- Term: Bone Diseases, Infectious

- ID: D000007239

- Term: Infections

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC01

- Name: Infections

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Ulcer

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcer

- ID: M12942

- Name: Osteomyelitis

- Relevance: HIGH

- As Found: Osteomyelitis

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5129

- Name: Bone Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4321

- Name: Osteomyelitis

- Relevance: HIGH

- As Found: Osteomyelitis

### Condition Browse Module - Meshes

- ID: D000010019

- Term: Osteomyelitis

- ID: D000003668

- Term: Pressure Ulcer

- ID: D000014456

- Term: Ulcer

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
