A Phase 2 interventional study of TTAX01 and Surgical resection and debridement in Non-healing Wound, Non-healing Diabetic Foot Ulcer and Diabetic Foot Infection, sponsored by BioTissue Holdings, Inc. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-15.
Sponsored by BioTissue Holdings, Inc · Phase 2, Interventional, and Treatment
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Among 381 studies in Diabetic Foot with a site in United States — 66 open to participants now, 85 under way, 3 of them phase 3. Diabetic Foot · United States.
Among the 381 studies in Diabetic Foot with a site in United States, this one is the 211th largest by enrollment of the 322 interventional ones that give a count, is one of 20 that started in 2017, is one of 43 in phase 2, and was the 181st registered.
1,078 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →66 of the 381 studies in Diabetic Foot with a site in United States are open now. Recruiting first, the newest first:
Applied Biologics, LLC · Sites in United States
Ages 18+
Biodynamik, Inc · Sites in United States
Ages 22+
Lakewood-Amedex Inc · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
Reprise Biomedical, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
381 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 54 · Phase 3 37 · Phase 4 31
First in 1994; this study’s year is marked. 20 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 60 across 848 interventional studies indexed under Diabetic Foot.
Median enrollment 60 across the 322 interventional studies, 138 across the 58 observational. Of the 249 that completed or were terminated, 89 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
253 of 381 have an industry lead sponsor. The 10 most frequent:
BioTissue Holdings, Inc is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
BioTissue Holdings, Inc has 4 studies filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
34 of the studies in Diabetic Foot with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05369052Phase 3MicuRxSafety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) | 2027-06-30 |
| NCT07852338Phase 3Applied Biologics, LLCa Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers | 2027-09 |
| NCT06420245Legacy Medical ConsultantsClinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | 2026-11 |
| NCT06449638StimLabsModified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs | 2026-11 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
Add all 34 to your calendar (.ics) → With an account.
Among the 381 studies in Diabetic Foot with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.
The hypothesis under study is that one or more applications of TTAX01 to the wound surface of a well debrided, complex diabetic foot ulcer managed with appropriate antibiotic therapy will result in a higher probability of complete healing than would be expected from management with standard care alone. In this open label Phase 2 pilot trial, all subjects will receive the intervention over a maximum period of 16 weeks. Eligible consenting subjects will undergo a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue. TTAX01 will be applied to the debrided wound bed at baseline, and if healing is not evident, it will be applied again at 4 week intervals. At each weekly visit the wound will be further debrided as necessary.
Consenting subjects who qualify for enrollment will undergo an aggressive surgical debridement at the baseline visit, including biopsies of bone for histology and microbiologic testing at the start and completion of debridement. Systemic antibiotics will be given empirically, with adjustments made on the basis of culture and sensitivity results. New or recurrent infections will be managed with additional debridement and adjustment or addition of appropriate systemic antibiotics. The test article, TTAX01, will be sutured to the debrided wound bed at baseline and again at 4 week intervals over the 16 week treatment period for wounds that do not show evidence of healing. For wounds that do show evidence of healing, additional applications of TTAX01 will be withheld, based on observations from retrospective case series.
Subjects whose wounds close prior to 16 weeks will move directly to a 2 week confirmation of closure period. Subjects whose wounds have not closed by the end of 16 weeks will exit the trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible consenting subjects will undergo a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue. A six week course of systemic antibiotics will be used to resolve baseline infection. TTAX01 will be applied to the debrided wound bed at baseline, and if healing is not evident, it will be applied again at 4 week intervals. At each weekly visit the wound will be further debrided as necessary.
Biological: TTAX01 · Procedure: Surgical resection and debridement · Drug: Systemic antibiotics · Device: Off-loading
TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.
Perform surgical sharp debridement in the OR, to remove: * infectious agents and biofilms (purulence), * all debris, eschar, callus and macerated non-viable tissue from the wound base, and * dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge. Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.
Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.
Provide off-loading device appropriate to the location of wound with full length boot or total contact cast
Number of Subjects With Complete Wound Healing
Proportion of subjects with complete wound healing observed over the 16-week treatment period. Complete wound healing was defined as an initial observation of closure, followed by two confirmatory visits two weeks apart.
Time frame: 16-weeks
Time to Complete Wound Healing
Time in number of days to complete wound closure over the 16 week treatment period, starting from enrollment to the time of the initial observation of wound closure
Time frame: up to 16 weeks
Percent Change in Wound Surface Area
Rate of wound closure, specifically percent change in the wound surface area (cm2) at each visit from baseline for assessing the rate of wound closure in area. Only percent change in wound surface area at week 16 reported.
Time frame: at week 16
| Milestone | TTAX01 Plus Standard Care |
|---|---|
| Started | 32 |
| Completed | 30 |
| Not completed | 2 |
Proportion of subjects with complete wound healing observed over the 16-week treatment period. Complete wound healing was defined as an initial observation of closure, followed by two confirmatory visits two weeks apart.
| participants | TTAX01 Plus Standard Care |
|---|---|
| Number of Subjects With Complete Wound Healing | 16 |
Time in number of days to complete wound closure over the 16 week treatment period, starting from enrollment to the time of the initial observation of wound closure
| weeks | TTAX01 Plus Standard Care |
|---|---|
| Time to Complete Wound Healing | 12.8 ± 4.3 |
Rate of wound closure, specifically percent change in the wound surface area (cm2) at each visit from baseline for assessing the rate of wound closure in area. Only percent change in wound surface area at week 16 reported.
| Percent Change | TTAX01 Plus Standard Care |
|---|---|
| Percent Change in Wound Surface Area | 90.93 (84.54 to 95.31) |
Collected over The maximum time in the study for any subject was 21 weeks, with 1 week in screening and assuming wound healing occurs at week 16 followed by 2 weeks of observation for confirmation of closure, and a final exit visit 14 days later.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TTAX01 Plus Standard Care | 0/32 (0%) | 7/32 (21.9%) | 19/32 (59.4%) |
| Event | TTAX01 Plus Standard Care |
|---|---|
| OsteomyelitisInfections and infestations | 3/32 |
| non-cardiac chest painGeneral disorders | 1/32 |
| gastroparesisEndocrine disorders | 1/32 |
| Bilateral Pleural EffusionsRespiratory, thoracic and mediastinal disorders | 1/32 |
| recurrent transient ischemic attackVascular disorders | 1/32 |
| Event | TTAX01 Plus Standard Care |
|---|---|
| BlisterSkin and subcutaneous tissue disorders | 4/32 |
| DiarrhoeaGastrointestinal disorders | 3/32 |
| Osteomyelitis acuteInfections and infestations | 3/32 |
| AnaemiaBlood and lymphatic system disorders | 2/32 |
| Diabetes mellitus inadequate controlEndocrine disorders | 2/32 |
| Diabetic FootEndocrine disorders | 2/32 |
| Limb injuryInjury, poisoning and procedural complications | 2/32 |
| Skin ulcerSkin and subcutaneous tissue disorders | 2/32 |
| Skin macerationSkin and subcutaneous tissue disorders | 2/32 |
| Age, Customized(participants) | TTAX01 Plus Standard Care |
|---|---|
| < 65 years | 23 |
| > or = to 65 years | 9 |
| Sex: Female, Male(Participants) | TTAX01 Plus Standard Care |
|---|---|
| Female | 1 |
| Male | 31 |
| Race/Ethnicity, Customized(Participants) | TTAX01 Plus Standard Care |
|---|---|
| Alaskan Native/American Indian | 1 |
| Black/African American | 8 |
| White/Caucasian | 22 |
| Other, not specified | 1 |
| Region of Enrollment(participants) | TTAX01 Plus Standard Care |
|---|---|
| United States | 32 |
| Subject presents with history, signs or symptoms leading to a clinical suspicion of osteomyelitis(Participants) | TTAX01 Plus Standard Care |
|---|---|
| Count of participants | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Jan 2019, 15 months.
Results were first posted in Jun 2021, 2 years 5 months after primary completion. A results delay was requested in Mar 2020.
Of 31 phase 2 interventional studies under Diabetic Foot, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Allogenic cryopreserved human umbilical cord tissue
BioTissue Holdings, Inc