PelloGraft + SanoGraft for Foot and Leg Ulcers
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Surgenex
No Placebo Group
Trial Summary
What is the purpose of this trial?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. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.
What safety data exists for PelloGraft and SanoGraft for foot and leg ulcers?The provided research does not contain any safety data for PelloGraft or SanoGraft for foot and leg ulcers. The studies focus on antiemetic drugs for postoperative nausea and vomiting, not on treatments for ulcers.2381014
What data supports the idea that PelloGraft + SanoGraft for Foot and Leg Ulcers is an effective treatment?The available research does not provide any data or studies related to the effectiveness of PelloGraft + SanoGraft for Foot and Leg Ulcers. The studies mentioned focus on different medical conditions and treatments, specifically related to anorectal malformations and surgical procedures, not on foot and leg ulcers or the use of PelloGraft + SanoGraft.1691215
Is PelloGraft, SanoGraft a promising treatment for foot and leg ulcers?PelloGraft and SanoGraft are promising treatments for foot and leg ulcers because they offer innovative ways to help wounds heal. These treatments can be more effective than traditional methods, especially for ulcers that are hard to heal. They use advanced techniques to promote healing and reduce the chance of ulcers coming back.4571113
Do I need to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on parenteral corticosteroids or cytotoxic agents for 7 consecutive days during the 30 days before screening, you may be excluded. Chronic oral steroid use is allowed if the dose is less than 10 mg per day of prednisone.
Eligibility Criteria
This trial is for individuals with diabetic foot ulcers (DFU) or venous leg ulcers (VLU). Participants should be suitable for treatment with the study products and meet specific health criteria set by the researchers. Details on who can join are not fully provided here.Inclusion Criteria
My blood flow to my affected limb is confirmed to be adequate.
I am 18 years old or older.
I have been diagnosed with diabetes.
My wound is on my foot, ankle, or leg.
I have a diabetic foot ulcer or venous leg ulcer between 1.0 and 25 cm2, or a venous leg ulcer between 1.0 and 50 cm2.
Exclusion Criteria
I have an active infection or a serious wound issue.
I am currently receiving treatment for cancer.
I have a bone infection or exposed bones confirmed by a doctor's exam or imaging tests.
Treatment Details
The trial compares two treatments: PelloGraft for DFUs and SanoGraft for VLUs, against standard wound care practices. It measures how fast wounds heal, reduction in wound size, and number of applications needed.
2Treatment groups
Experimental Treatment
Group I: Arm 2 SanoGraftExperimental Treatment1 Intervention
SanoGraft treatment for venous leg ulcers vs Standard of Care treatment for venous leg ulcers
Group II: Arm 1 PelloGraftExperimental Treatment1 Intervention
PelloGraft treatment for diabetic foot ulcers versus Standard of Care treatment for diabetic foot ulcers
PelloGraft is already approved in United States for the following indications:
🇺🇸 Approved in United States as PelloGraft for:
- Diabetic foot ulcers
- Venous leg ulcers
- Pressure ulcers
Find a clinic near you
Research locations nearbySelect from list below to view details:
ILD ResearchVista, CA
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Who is running the clinical trial?
SurgenexLead Sponsor
References
Results in the treatment of anorectal malformations with special regard to the histology of the rectal pouch. [2005]The results of surgery for anorectal malformation (ARM) in 536 children treated between 1962 and 1993 are presented. Before 1985, patients underwent an abdominoperineal pullthrough for high and intermediate type of ARM, whereas cut-back procedures or perineoproctoplasty were performed in low type. Since 1985, we have changed our policy and performed a modified posterior sagittal anorectoplasty (PSARP) for intermediate type of ARM, eventually combined with an abdominal mobilization for high type. Perineoproctoplasty was reserved for low type of ARM. Data of 143 patients of Group 1 and 85 patients of Group 2 were available for follow-up. Continence was compared using a clinical score. Good or fair continence was found in 82% of patients operated on before 1985 (low type 85% good, 15% fair, intermediate type 17% good, 50% fair, high type 12% good, 37% fair), comparing to 93% in children treated after 1985 according to the new regimen (low type 88% good, 6% fair, intermediate type 59% good, 35% fair, high type 43% good, 47% fair). Liquid stools and inability to retain bowel contents were the main problem in the older series, whereas incontinence could often be attributed to constipation with overflow incontinence in the recently treated group of patients. Analysis of the innervation of fistula and distal rectal pouch in a prospective study comprising 40 of our most recent patients showed normal innervation in only 5% of patients, whereas 66% had neuronal intestinal malformations (NIM) including aganglionosis, NID and hypoganglionosis.(ABSTRACT TRUNCATED AT 250 WORDS)
The dose-response relation and cost-effectiveness of granisetron for the prophylaxis of pediatric postoperative emesis. [2019]Postoperative nausea and vomiting (PONV) may delay discharge from hospital after ambulatory surgery. The antiserotonin agents, ondansetron and granisetron, provide effective prophylaxis against chemotherapy-induced and postoperative nausea and vomiting in adults, but are expensive. We determined the dose-response relation of granisetron and the financial impact of using this drug in preventing PONV after pediatric outpatient surgery.
Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials. [2022]The authors reviewed efficacy and safety data for ondansetron for preventing postoperative nausea and vomiting (PONV).
Skin grafting for venous leg ulcers. [2018]Venous leg ulceration is a common, recurring, disabling condition affecting up to 1% of adults. Treatment is aimed at healing with simple dressings and compression bandages / stockings. Unfortunately in some cases this treatment is unsuccessful with ulcers remaining open for months or years. In order to stimulate healing, some clinicians use skin grafts. These skin grafts may be taken from the patients own uninjured skin (e.g. thigh), may be grown from the patient's skin cells into a dressing, (both known as autografts) or applied as a sheet of bioengineered skin grown from a donor cells (known as an allograft). Preserved skin from other animals, e.g. pigs, have also been used and these are known as xerografts.
Skin grafting for venous leg ulcers. [2020]Venous leg ulceration is a common and disabling condition which often recurs. It affects up to one in 100 adults at some time. The usual treatments are simple dressings and compression bandages or stockings. Unfortunately, in some cases this treatment is unsuccessful, with ulcers remaining open for months or years. Sometimes skin grafts are used to stimulate healing. These skin grafts may be taken from the patient's own uninjured skin, may be grown from the patient's skin cells into a dressing (autografts), or applied as a sheet of bioengineered skin grown from donor cells (allograft). Preserved skin from other animals, such as pigs, has also been used; these grafts are known as xerografts.
Laparoscopic treatment of rectovaginal fistulas. Feasibility, technical details, and functional results of a rare anorectal malformation. [2022]Rectovaginal fistulas are a rare variety of anorectal malformations. Eight patients with this anomaly among 420 children with anorectal malformations were treated in our center. We used a laparoscopic approach in 5 of the children. The aim of this study is to define the feasibility and technical details of laparoscopy in the treatment of these patients as compared with those treated by posterior sagittal anorectoplasty (PSARP) and to evaluate the preliminary results.
Management of chronic wounds with an innovative absorbent wound dressing. [2012]To evaluate the efficacy and tolerability of an innovative absorbent wound dressing (UrgoClean; Laboratoires Urgo) in the local management of venous leg ulcers and pressure ulcers, during the sloughy stage of the healing process.
A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post-laparoscopic cholecystectomy emetic symptoms. [2021]Granisetron hydrochloride, a selective serotonin receptor antagonist, has been used to treat established postoperative nausea and vomiting (PONV). Dexamethasone has been shown to reduce the incidence of chemotherapy-induced emesis when added to an antiemetic regimen.
Complete Posterior Sagittal Anorectal Mobilization (PSAM): A new surgical approach for pediatric pelvic-perineal tumor resections. [2018]Diffuse or massive tumors involving the perineal and pelvic compartments may require aggressive surgical treatment in children. The authors, propose and present their results using a Posterior Sagittal Anorectal Mobilization (PSAM) METHODS: The oncologic patient is placed in a prone position with the pelvis elevated, without a previous colostomy. A 10 Ch bladder catheter is positioned. A midline sagittal incision is performed from the coccyx to the posterior margin of the anus. Fine electrocautery is used to obtain an accurate dissection all around the anal margin itself. The incisional so involves the midline dissection into the perineal body. Reconstruction is achieved by the classical pelvic-perineal anatomical structure approximation.
Comparison of palonosetron and dexamethasone with ondansetron and dexamethasone for postoperative nausea and vomiting in postchemotherapy ovarian cancer surgeries requiring opioid-based patient-controlled analgesia: A randomised, double-blind, active controlled study. [2022]Patients undergoing ovarian cancer surgery after chemotherapy and requiring opioid-based patient-controlled analgesia (PCA) are at high-risk of postoperative nausea and vomiting (PONV). We aimed to assess the effect of palonosetron and dexamethasone combination for these patients for prevention of PONV.
A Meta-Analysis of the Outcomes of Split-Thickness Skin Graft on Diabetic Leg and Foot Ulcers. [2022]Diabetic lower limb ulcers are a serious complication to diabetes that could lead to amputation and death. Split-thickness skin graft (STSG) has been proposed by some authors to treat noninfected diabetic wounds, mainly those found in the leg and on the dorsum of the foot. No quantitative evidence synthesis over this technique has been reported in the literature. The study is a meta-analysis on the effectiveness of STSG in treating diabetic leg and foot ulcers. Electronic databases were searched from inception. No limitation was imposed on study design. Eleven studies comprising 757 patients with 759 foot/leg ulcers were included. After a mean period of 2 years, 85.5% (95% confidence interval [CI] = 0.766-0.925) of ulcers were healed over a mean time of 5.35 ± 2.25 weeks, with a recurrence rate of 4.2% (95% CI = 0.009-0.096), an infection rate of 4.4% (95% CI = 0.013-0.092), and a regrafting rate of 12.1% (95% CI = 0.053-0.212). Infection was the only reported donor site morbidity with a frequency of 1.74% (95% CI = 0.001-0.048). These weighted values are found to be noticeably superior to those reported in the literature following standard conventional care. The results of the review make STSG the ideal method to treat noninfected recurrent or recalcitrant ulcers of the leg and dorsal foot. Furthermore, the authors argue that STSG should be used more frequently in the management of such wounds. The findings should encourage future prospective investigations.
Primary Posterior Sagittal Anorectoplasty Outcomes for Rectovestibular and Perineal Fistulas Using an Accelerated Pathway: a Single Institution Study. [2022]Posterior sagittal anorectoplasty (PSARP) is the most common surgical treatment for patients with anorectal malformations. Such patients are often subjected to prolonged nil per os (NPO), antibiotic use, and use of parenteral nutrition. Our aim was to review our institutional experience with patients undergoing PSARP using an accelerated standardized postoperative pathway.
[Surgical treatment for chronic leg ulcer]. [2020]Leg ulcers pose a therapeutic challenge due to a chronic healing process. Conservative wound dressings are initially the treatment of choice, but their effectiveness in therapy-refractory wounds is limited. In these cases, multiple mechanical debridement in combination with split-thickness skin grafts (STSG) are a simple and safe treatment option for ulcer coverage. Additional therapy with negative pressure wound therapy (NPWT) improves the surgical outcome by promoting ulcer granulation, continuous elimination of exsudate and blood as well as increased contact pressure on the skin graft. After transplantation, the split skin graft requires daily wound dressings until it has fully healed after approximately 3 weeks.
Antiemetic Efficacy of Palonosetron Compared with the Combination of Ondansetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynaecological Surgery. [2023]For the prevention of PONV, we evaluated the efficacy of palonosetron compared with ondansetron along with dexamethasone in patients undergoing laparoscopic gynaecological surgery.
Rectovaginal Fistulas: Comparative Analysis of Laparoscopic Assisted Pullthrough and Posterior Sagittal Anorectoplasty. [2023]Compare the laparoscopic treatment (LT) and the posterior sagittal anorectoplasty treatment (ST) of the rectovaginal fistulas (RvaF) in a single center. We have previously reported feasibility and results of LT in this rare variety of anorectal malformations (ARM) [1-3].