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Compares treatment options for Diabetic Foot Ulcer
Official title Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
ClinicalTrials.gov ID: NCT06515093
What this study is testing
- What it's testing
- The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is at least 18 years of age
- Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
- Subject's wound is located on foot or ankle (DFU) or leg (VLU)
- Subject has diabetic foot ulcer \> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \> 1.0 cm2 and ≤ 50 cm2
- Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤...
You likely can't join if
- Subject is pregnant
- Subject with diagnosed diabetes has HbA1C \> 12 within 3 months Prior to randomization
- Subject has \> 30% reduction in wound size after 2-week run-in period
- Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
- Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
- Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is...
See the full eligibility criteria
- Subject is at least 18 years of age
- Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
- Subject's wound is located on foot or ankle (DFU) or leg (VLU)
- Subject has diabetic foot ulcer \> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \> 1.0 cm2 and ≤ 50 cm2
- Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg
- Subject is willing and able to comply with all protocol requirements
- Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
- Subject is pregnant
- Subject with diagnosed diabetes has HbA1C \> 12 within 3 months Prior to randomization
- Subject has \> 30% reduction in wound size after 2-week run-in period
- Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
- Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
- Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose \< 10 mg per day of prednisone
- Subject is currently undergoing cancer treatment
- Subject has used biologic skin substitutes within 14 days of enrollment
- Subject has an allergy to suture material
- Subject has life expectancy less than six-months as assessed by the investigator
- Subject is participating in another clinical research study prior to this study completion
The study team makes the final eligibility decision.
Where it's taking place
- Vista, California, United States
- Tulsa, Oklahoma, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vista, California, United States; Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.