Wounds that won't heal — what the evidence shows

A wound that won’t close takes over a life in a way people who haven’t had one don’t expect. Appointments, dressings, the smell, the fear of what comes next. And often a long time without a clear answer.

That is a position people get sold things in. This page tries not to be one of those things.

The most useful thing a review here can do may be to tell you that the problem is not the dressing — it is the blood supply, or the infection, or the pressure on the wound. Those have real treatments, and they work.

	Standard wound care	Fix the underlying cause first	Standard care and explore this	Wait
What it is	Offloading, dressings, debridement, infection control, glycaemic management	Vascular treatment, drainage or surgery, getting diabetes under control	Continue standard care; a physician assesses whether a regenerative option is appropriate	Do nothing new for now
Who tends to consider it	Everyone, and it stays in place	More people than realise it — this is often the real answer	People whose wound persists despite proper care and whose underlying causes are addressed	People whose situation is about to change
What the evidence says	Strongest evidence in the field by far	Well established. A wound over a poor blood supply will not heal	Mixed — positive and negative randomised trials, mostly in one wound type	Chronic wounds tend not to improve on their own
Certainty	High	High	Low	Moderate

Column two is not a formality. A physician’s review often ends there, and when it does, that is the review working — not failing.

What this is. Amniotic membrane is the innermost layer of the sac that surrounds a baby before birth. It is donated after a planned caesarean delivery, then processed and preserved. It is human tissue, not a drug — which is part of why it is regulated the way it is.

What it is trying to do. That membrane spends nine months doing one specific job: holding a barrier intact between two organisms, while carrying signals that tell tissue to grow and tell inflammation to settle. A chronic wound is a wound where that second part has stopped — the healing process stalls partway and stays there. The idea being tested is that placing this tissue on the wound restarts a closure that has stopped.

Why researchers became interested. Because chronic wounds are common, expensive and genuinely hard to treat, and because the membrane is not a synthetic dressing: it arrives with the signalling already in it. It also has an unusual property — it is naturally low in the markers the immune system uses to recognise foreign tissue — which is why it can be used between unrelated people.

Why someone might reasonably discuss it with a physician. Because whether a wound is stalled for reasons a membrane could address — or for reasons it cannot, such as blood supply — is a clinical judgement, and it is the question that decides everything else.

Amniotic and placental membrane has more evidence behind it than anything else in this route.

Across randomised trials, membrane heals more wounds than standard care alone — and an independent review rates the certainty of that evidence as low. Both are true: one is about direction, the other about certainty.

The largest recent trial found nothing — in the hardest wounds. Complex diabetic foot ulcers: exposed bone or tendon, controlled bone infection. That is not the opposite of the positive trials. It is a boundary. The positive trials enrolled simpler ulcers, so the most useful reading is that membrane appears to help relatively uncomplicated wounds and has not been shown to help the most difficult ones.

That is not a rule about who can be evaluated. If your wound has exposed bone or tendon, the evidence supporting benefit is substantially less convincing for a wound like yours — worth knowing before you decide, and not a reason to skip the evaluation. The individual wound still needs clinical assessment.

Nearly all of this research was funded by the companies developing or selling the products. That is common in this field and does not, by itself, invalidate the findings. It is, however, one reason independent confirmation is important.

Mesenchymal cell therapy applied into the wound is experimental — and most trials of cells in diabetic feet inject them into muscle to improve blood supply, which is a different treatment for a different problem.

Every trial behind this section — sizes, effects, funding and dates — is one click down.

Clinical trial safety should not be interpreted as a guarantee that every product or provider in the marketplace is equally safe. What happened in this market is in the next section.

It doesn’t show high-quality evidence. Independent reviewers rate the certainty of this literature as low to moderate.

It doesn’t show that anything replaces fixing the cause. No product heals a wound that has too little blood reaching it. That is not a caveat — it is the single most important thing on this page.

And it doesn’t show that this market has been driven by evidence. Medicare spending on these products went from 256 million dollars in 2019 to over 10 billion in 2024, while the number of patients treated roughly doubled.

The rest of the figures, and where they come from.

None of that means the products don’t work. The trials are real and some are positive. It means that the volume of use in this field ran far ahead of the evidence for it, and that a patient being offered one of these products is entering a market where that happened.

In the United States, amniotic and placental membranes are regulated as human tissue, not as medicines — a pathway that does not require the manufacturer to prove the product works before selling it. In Mexico, regenerative medicine is legal and requires authorisation from the health regulator, and what that authorisation does not do is assess whether a treatment works. The same limitation in a different system.

So how you check matters more than where you go. Verify a clinic by name and address against the regulator’s own registry — not against what its website says. Why that matters, and how approval works →

Whether the cause has really been addressed. It is worth asking your own team directly: has my blood supply been assessed? Is there infection? Is pressure being kept off it? If any answer is no, that is where the next improvement will come from.

What another few months costs you. Chronic wounds carry a risk that grows with time. That argues both ways — for not waiting, and for not spending the time on something unproven.

How you weigh mixed evidence. Some people see several positive trials and find that enough. Others see one large negative trial and stop. Neither is irrational.

Most of these mean something else needs doing first — not that nothing can be done.

This route is about wounds that have not healed as expected despite appropriate standard care — diabetic foot ulcers, chronic venous ulcers, pressure injuries, surgical wounds healing slowly, and some traumatic wounds that have not closed. Burns are not part of it: they are a different clinical area and usually need dedicated burn care.

• Standard care hasn’t been tried properly, or the cause hasn’t been addressed. That is the phrase doing the work above, and it is the most common reason a wound is still open. - Your blood supply hasn’t been assessed or treated. A wound over critical ischemia will not heal. This needs vascular assessment, not a graft. - You have an active infection that isn’t controlled. That needs urgent treatment.
• Your wound needs surgery. Some wounds need debridement or reconstruction before anything else can work. - Your diabetes is poorly controlled to the point that it is preventing the wound from healing. - You’re not willing to share your medical records. A responsible review cannot be carried out without them.

And if you have a fever, spreading redness, a wound that is getting rapidly worse, or a foot that is cold, pale or suddenly painful — that is an emergency. Go now. Not to us.

1. Has my blood supply been properly assessed, and by whom?
2. What would you fix before trying anything regenerative?
3. What published evidence exists for this in my kind of wound — not in diabetic foot ulcers, if that’s not what I have?
4. Where was this product made, and under what registration?
5. What testing is done on each batch before release?
6. How does this compare to a collagen dressing, which is cheaper and has been studied?
7. What would make you tell me I’m not a candidate?

Print this list.

Wounds are often managed by a family member — the dressings, the appointments, the watching.

Print sections 8 and 9. Section 8 is how to tell whether something more urgent is being missed. Section 9 works in a room with any wound specialist.

And take photographs. A physician can tell a great deal from a clear photo, and it is the one piece of a wound assessment that doesn’t require a clinic.

You can begin a review on their behalf — but before any medical record is shared or the clinical review continues, the patient must consent.

1. You send records through a secure upload link, including photographs of the wound if you have them. What the physician needs for this review lists exactly what to gather.
2. An independent physician reviews the case. Some patients are advised that this treatment is not appropriate for their situation — and often that conventional care should come first.
3. If they consider it appropriate, they speak with you directly and explain any applicable fees at that point. Human Paths does not set, publish, collect or process payment for healthcare services.
4. You decide.

The treating physician confirms the final schedule after reviewing your case.

The request form is linked from the home page, deliberately not from here: reading the evidence and asking for a review are two separate steps.